Products

KDC supplies a large number of pharmaceutical products e.g.:
Pharmaceutical Trade Name Active Substance Marketing Authorisation Holder Medical Use
Pharmaceutical Trade Name Active Substance Marketing Authorisation Holder Medical Use
Abasaglar (previously Abasria) insulin glargine Eli Lilly Regional Operations GmbH Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Abilify aripiprazole Otsuka Pharmaceutical Europe Ltd Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Abilify Maintena aripiprazole Otsuka Pharmaceutical Europe Ltd Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Abraxane paclitaxel Celgene Europe Ltd   Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Abseamed epoetin alfa Medice Arzneimittel Pütter GmbH & Co. KG Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy). Abseamed can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). Abseamed can be used to reduce exposure to allogeneic blood transfusions in adult non iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.
Accofil filgrastim Accord Healthcare Ltd Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy. Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Aclasta zoledronic acid Novartis Europharm Limited Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture. Treatment of Paget's disease of the bone.
Actelsar HCT telmisartan / hydrochlorothiazide Actavis Group hf Treatment of essential hypertension. Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Actos pioglitazone hydrochloride Takeda Pharma A/S Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy: in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.
Actraphane insulin human Novo Nordisk A/S Treatment of diabetes mellitus
Actrapid human insulin Novo Nordisk A/S Treatment of diabetes mellitus.
Adasuve loxapine Alexza UK Ltd Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.
Adcetris brentuximab vedotin Takeda Pharma A/S Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): following autologous stem-cell transplant (ASCT) or; following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Adcetris is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large-cell lymphoma (sALCL).
Adcirca (previously Tadalafil Lilly) tadalafil Eli Lilly Nederland B.V. Adcirca is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organization functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Adempas riociguat Bayer Pharma AG Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1). Pulmonary arterial hypertension (PAH) Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1).
Adenuric febuxostat Menarini International Operations Luxembourg S.A. (MIOL) 80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuricis indicated in adults. 120 mg strength: Adenuricis indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuricis indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Adenuricis indicated in adults.
Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) GlaxoSmithKline Biologicals S.A. Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance (see sections 4.2 and 5.1).
Adrovance alendronate sodium trihydrate / colecalciferol Merck Sharp & Dohme Ltd Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Adrovance reduces the risk of vertebral and hip fractures.
Advagraf tacrolimus Astellas Pharma Europe B.V. Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Advate octocog alfa Baxter AG Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). Advate does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.
Aerinaze desloratadine / pseudophedrine sulphate Merck Sharp & Dohme Ltd.   Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Aerius desloratadine Merck Sharp & Dohme Ltd   Aerius is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.
Afinitor everolimus Novartis Europharm Limited Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Aflunov influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23) Novartis Vaccines Influenza Srl   Active immunisation against H5N1 subtype of influenza-A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/05 (H5N1)-like strain.Aflunov should be used in accordance with official recommendations.
Akynzeo netupitant / palonosetron hydrochloride Helsinn Birex Pharmaceuticals Ltd Akynzeo is indicated in adults for the: Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy. Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Aldara imiquimod Meda AB Imiquimod cream is indicated for the topical treatment of: external genital and perianal warts (condylomata acuminata) in adults; small superficial basal-cell carcinomas (sBCCs) in adults; clinically typical, non-hyperkeratotic, non-hypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and / or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Aldurazyme laronidase Genzyme Europe B.V. Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease.
Alimta pemetrexed Eli Lilly Nederland B.V. Malignant pleural mesothelioma Alimta in combination with cisplatin is indicated for the treatment of chemotherapy-nave patients with unresectable malignant pleural mesothelioma. Non-small-cell lung cancer Alimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology. Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.
Alli (previously Orlistat GSK) orlistat Glaxo Group Ltd. Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.
Aloxi palonosetron hydrochloride Helsinn Birex Pharmaceuticals Ltd. Aloxi is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Aloxi is indicated in paediatric patients 1 month of age and older for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Altargo retapamulin Glaxo Group Ltd Short term treatment of the following superficial skin infections: impetigo. infected small lacerations, abrasions, or sutured wounds. See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Ambirix hepatitis-A virus (inactivated) / hepatitis-B surface antigen GlaxoSmithKline Biologicals S.A. Ambirix is for use in non-immune persons from one year up to and including 15 years of agefor protection against hepatitis-A and hepatitis-B infection. Protection against hepatitis-B infections may not be obtained until after the second dose. Therefore: Ambirix should be used only when there is a relatively low risk of hepatitis-B infection during the vaccination course; it is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.
Ameluz 5-aminolevulinic acid hydrochloride Biofrontera Bioscience GmbH Treatment of actinic keratosis of mild to moderate intensity on the face and scalp (Olsen grade 1 to 2).
Ammonaps sodium phenylbutyrate Swedish Orphan Biovitrum International AB Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase. It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Amyvid florbetapir (18F) Eli Lilly Nederland B.V. This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical indicated for positron-emission-tomography (PET) imaging of amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimers disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.
Angiox bivalirudin The Medicines Company UK Ltd Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/ non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention. Angiox should be administered with aspirin and clopidogrel.
Anoro umeclidinium bromide / vilanterol trifenatate Glaxo Group Ltd Anoro is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Apidra insulin glulisine sanofi-aventis Deutschland GmbH Treatment of adults, adolescents and children,six years or older with diabetes mellitus, where treatment with insulin is required
Aprovel irbesartan Sanofi Clir SNC Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.
Aptivus tipranavir Boehringer Ingelheim International GmbH Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years. In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.
Aranesp darbepoetin alfa Amgen Europe B.V. Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Arava leflunomide Sanofi-Aventis Deutschland GmbH Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Ariclaim duloxetine Eli Lilly Nederland B.V. Treatment of diabetic peripheral neuropathic pain. Ariclaim is indicated in adults.
Aripiprazole Pharmathen aripiprazole Pharmathen S.A. Aripiprazole Pharmathen is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Pharmathen is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Pharmathen is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Aripiprazole Zentiva aripiprazole Zentiva, k.s. Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Arixtra fondaparinux sodium Aspen Pharma Trading Limited 1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery. Prevention ofVTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis. 2.5-mg/0.5-ml solution for injection Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent ( 120 mins) invasive management (PCI) is not indicated. infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injection Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
Arzerra ofatumumab Novartis Europharm Ltd Treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab.
Atosiban SUN atosiban acetate Sun Pharmaceutical Industries Europe B.V. Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds duration at a rate of 4 per 30 minutes; a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of 50%; a gestational age from 24 until 33 completed weeks; a normal foetal heart rate.
Atriance nelarabine Novartis Europharm Limited Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. Due to the small patient populations in these disease settings, the information to support theseindications is based on limited data.
Atripla efavirenz / emtricitabine / tenofovir disoproxil fumarate Bristol-Myers Squibb and Gilead Sciences Limited Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen. The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla. No data are currently available from clinical studies with Atripla in treatment-naive or in heavily pretreated patients. No data are available to support the combination of Atripla and other antiretroviral agents.
ATryn antithrombin alfa GTC Biotherapeutics UK Limited ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn is normally given in association with heparin or low molecular weight heparin.
Aubagio teriflunomide Sanofi-aventis Groupe   Treatment of adult patients with relapsing-remitting multiple sclerosis (MS).
Avamys fluticasone furoate Glaxo Group Limited Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Avastin bevacizumab Roche Registration Limited Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human-epidermal-growth-factor-receptor-2 (HER2) status. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small-cell lung cancer other than predominantly squamous cell histology. Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and / or metastatic renal-cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian-tube, or primary peritoneal cancer. Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelian-ovarian, fallopian-tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular-endothelial-growth-factor (VEGF) inhibitors or VEGF-receptor-targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see Section 5.1).
Avonex interferon beta-1a Biogen Idec Ltd Avonex is indicated for the treatment of: patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses; patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite MS. Avonex should be discontinued in patients who develop progressive MS.
Axura memantine hydrochloride Merz Pharmaceuticals GmbH Treatment of patients with moderate to severe Alzheimer's disease.
Azarga brinzolamide / timolol Alcon Laboratories (UK) Ltd Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.
Azilect rasagiline Teva Pharma GmbH Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end-of-dose fluctuations.
Azomyr desloratadine Merck Sharp & Dohme Ltd   Azomyr is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.
Azopt brinzolamide Alcon Laboratories (UK) Ltd. Azopt is indicated to decrease elevated intraocular pressure in: ocular hypertension; open-angle glaucomaas monotherapy in adultpatients unresponsive to beta-blockers or in adultpatients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.
Baraclude entecavir Bristol-Myers Squibb Pharma EEIG Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. decompensated liver disease (see section 4.4). For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Bemfola follitropin alfa Finox Biotech AG In adult women Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT) Follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level 1.2 IU/l In adult men Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy
BeneFIX nonacog alfa Pfizer Ltd   Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).
Benlysta belimumab Glaxo Group Ltd. Benlysta is indicated as add-on therapy in adult patients with active, auto-antibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy.
Beromun tasonermin Boehringer Ingelheim International GmbH Beromun is indicated in adults as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft-tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated-limb perfusion (ILP).
Betaferon interferon beta-1b Bayer Pharma AG Betaferon is indicated for the treatment of patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Betmiga mirabegron Astellas Pharma Europe B.V. Symptomatic treatment of urgency. Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladdersyndrome.
Bexsero recombinant Neisseria meningitidis group-B NHBA fusion protein /recombinant Neisseria meningitidis group-B NadA protein /recombinant Neisseria meningitidis group B fHbp fusion protein /outer membrane vesiclesfrom Neisseria meningitidis group-B strain NZ98 / 254 measured as amount of total protein containing the PorA P1.4 Novartis Vaccines and Diagnostics S.r.l. Active immunisation against invasive disease caused by Neisseria meningitidis serogroup-B strains.
Binocrit epoetin alfa Sandoz GmbH Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis (see section 4.4); treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (see section 4.4); Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Biograstim filgrastim AbZ-Pharma GmbH Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Biopoin epoetin theta Teva GmbH Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
BiResp Spiromax budesonide / formoterol fumarate dihydrate Teva Pharma B.V. BiResp Spiromax is indicated in adults 18 years of age and older only. Asthma BiResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting 2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and as needed inhaled short-acting 2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting 2 adrenoceptor agonists. Chronic obstructive pulmonary disease Symptomatic treatment of patients with severe chronic obstructive pulmonary disease - COPD (FEV1 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Bondronat ibandronic acid Roche Registration Ltd. Bondronat is indicated for: prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases; treatment of tumour-induced hypercalcaemia with or without metastases.
Bonviva ibandronic acid Roche Registration Ltd. Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Bortezomib Accord bortezomib Accord Healthcare Ltd Bortezomib Accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib Accord in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for highdose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Accord in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for highdose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Bosulif bosutinib (as monohydrate) Pfizer Ltd Bosulif is indicated for the treatment of adult patients with chronic-phase, accelerated-phaseand blast-phasePhiladelphia-chromosome-positive chronic myelogenous leukaemiapreviously treated with one or more tyrosine-kinase inhibitors and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Bretaris Genuair aclidinium bromide, micronised AstraZeneca AB Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Bridion sugammadex Merck Sharp & Dohme Limited Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium-induced blockade in children and adolescents.
Brilique ticagrelor AstraZeneca AB Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]), including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
Brimica Genuair aclidinium / formoterol fumarate dihydrate AstraZeneca AB Brimica Genuair is indicated as a maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Brinavess vernakalant hydrochloride Cardiome UK Limited Rapid conversion of recent-onset atrial fibrillation to sinus rhythm in adults: for non-surgery patients: atrial fibrillation 7 days duration; for post-cardiac-surgery patients: atrial fibrillation 3 days duration.
Brintellix vortioxetine H. Lundbeck A/S Treatment of major depressive episodes in adults
Bronchitol mannitol Pharmaxis Pharmaceuticals Limited Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Buccolam midazolam ViroPharma SPRL Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (fromthree months toless than18 years). Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy. For infants betweenthree and sixmonths of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Budesonide/Formoterol Teva budesonide / formoterol fumarate dihydrate Teva Pharma B.V. Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only. AsthmaBudesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting 2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and as needed inhaled short-acting 2 adrenoceptor agonists.or in patients already adequately controlled on both inhaled corticosteroids and long-acting 2 adrenoceptor agonists. COPDSymptomatic treatment of patients with severe COPD (FEV1 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Budesonide/Formoterol Teva Pharma B.V. budesonide / formoterol Teva Pharma B.V. Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting 2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and as needed inhaled short-acting 2 adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting 2 adrenoceptor agonists.
Busilvex busulfan Pierre Fabre Médicament Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen. Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Busulfan Fresenius Kabi busulfan Fresenius Kabi Oncology Plc. Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Bydureon exenatide AstraZeneca AB Bydureon is indicated for treatment of type-2 diabetes mellitus in combination with: metformin; sulphonylurea; thiazolidinedione; metformin and sulphonylurea; metformin and thiazolidinedione; in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
Byetta exenatide AstraZeneca AB Byetta is indicated for treatment of type-2 diabetes mellitus in combination with: metformin; sulphonylureas; thiazolidinediones; metformin and a sulphonylurea; metformin and a thiazolidinedione; in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.
Caelyx doxorubicin hydrochloride Janssen-Cilag International N.V. Caelyx is indicated: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk; for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen; in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant; for treatment of AIDS-related Kaposis sarcoma (KS) in patients with low CD4 counts (200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standarddoxorubicin (or other anthracycline).
Cancidas (previously Caspofungin MSD) caspofungin Merck Sharp & Dohme Ltd Treatment of invasive candidiasis in adult or paediatric patients; treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and / or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum ofseven days of prior therapeutic doses of effective antifungal therapy; empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
Capecitabine Accord capecitabine Accord Healthcare Ltd Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes stage-C) colon cancer. Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer. Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Accord in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Capecitabine Medac capecitabine medac Gesellschaft für klinische Spezialpräparate mbH Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes stage-C) colon cancer. Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer. Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Capecitabine SUN capecitabine Sun Pharmaceutical Industries Europe B.V. Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes stage-C) colon cancer. Capecitabine is indicated for the treatment of metastatic colorectal cancer. Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Capecitabine Teva capecitabine Teva Pharma B.V. Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes stageC) colon cancer. Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer. Capecitabine Teva is indicated for firstline treatment of advanced gastric cancer in combination with a platinumbased regimen. Capecitabine Teva in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Teva is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Caprelsa vandetanib AstraZeneca AB Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).
Carbaglu carglumic acid Orphan Europe S.A.R.L. Carbaglu is indicated in treatment of: hyperammonaemia due to N-acetylglutamate-synthase primary deficiency; hyperammonaemia due to isovaleric acidaemia; hyperammonaemia due to methymalonic acidaemia; hyperammonaemia due to propionic acidaemia.
Cayston aztreonam lysine Gilead Sciences International Limited Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
CellCept mycophenolate mofetil Roche Registration Ltd. CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Celsentri maraviroc ViiV Healthcare UK Limited Celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients.
Celvapan whole virion, inactivated containing antigen: A/California/07/2009 (H1N1)v Baxter AG Prophylaxis of influenza caused by A(H1N1)v 2009 virus. Celvapan should be used in accordance with official guidance.
Ceplene histamine dihydrochloride Meda AB Ceplene maintainance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.
Ceprotin human protein C Baxter AG Ceprotinis indicated in purpura fulminans and coumarin-induced skin necrosis in patients with severe congenital protein C deficiency. FurthermoreCeprotin is indicated for short-term prophylaxis in patients with severe congenital protein C deficiency if one or more of the following conditions are met: surgery or invasive therapy is imminent; while initiating coumarin therapy; when coumarin therapy alone is not sufficient; when coumarin therapy is not feasible.
Cerdelga eliglustat Genzyme Europe BV Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Cerezyme imiglucerase Genzyme Europe B.V. Cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: anaemia after exclusion of other causes, such as iron deficiency Thrombocytopenia Bone disease after exclusion of other causes such as Vitamin D deficiency hepatomegaly or splenomegaly
Cervarix human papillomavirus1 type 16 L1 protein / human papillomavirus type 18 L1 protein GlaxoSmithKline Biologicals S.A. Cervarix is a vaccine for use from the age of nine years for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic human-papillomavirus (HPV) types. The use of Cervarix should be in accordance with official recommendations.
Cetrotide cetrorelix Merck Serono Europe Ltd. Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques. In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.
Champix varenicline Pfizer Limited Champix is indicated for smoking cessation in adults.
Cholestagel colesevelam Genzyme Europe B.V. Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone. Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated. Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).
Cholib fenofibrate / simvastatin Abbott Healthcare Products Ltd Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL C levels when LDL C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
ChondroCelect characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins TiGenix NV Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults. Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1 and 5 cm.
Cialis tadalafil Eli Lilly Nederland B.V. Treatment of erectile dysfunction. In order for tadalafil to be effective, sexual stimulation is required. Cialis is not indicated for use by women.
Cimzia certolizumab pegol UCB Pharma SA   Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate.Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.Axial spondyloarthritisCimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: Ankylosing spondylitis (AS)Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Axial spondyloarthritis without radiographic evidence of ASAdults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and /or MRI, who have had an inadequate response to, or are intolerant to NSAIDs. Poriatic arthritisCimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Cinryze C1 inhibitor (human) ViroPharma SPRL   Treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). Routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.
Circadin melatonin RAD Neurim Pharmaceuticals EEC Limited Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Clopidogrel Acino clopidogrel Acino AG Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA) ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy Patients suffering from acute coronary syndrome: For further information please refer to section 5.1.
Clopidogrel Apotex (previously Clopidogrel Mylan Pharma) clopidogrel besilate Apotex Europe B.V. Prevention of atherothrombotic events. Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy; prevention of atherothrombotic and thromboembolic events in atrial fibrillation; in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonistsand who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of therothrombotic and thromboembolic events, including stroke.
Clopidogrel BGR (previously Zylagren) clopidogrel hydrogen sulphate Biogaran Prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Clopidogrel HCS clopidogrel hydrochloride HCS bvba   Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; Patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Clopidogrel Krka Clopidogrel hydrochloride Krka, d.d., Novo mesto Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Clopidogrel Krka d.d. (previously Zopya) clopidogrel hydrochloride Krka, d.d., Novo mesto Prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Clopidogrel Mylan clopidogrel hydrochloride Mylan S.A.S. Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: - Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Clopidogrel ratiopharm clopidogrel hydrogen sulphate Teva Pharma B.V. Prevention of atherothrombotic eventsClopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Clopidogrel ratiopharm GmbH clopidogrel Archie Samuel s.r.o. Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q wave-myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. For further information please refer to section 5.1.
Clopidogrel TAD clopidogrel hydrochloride Tad Pharma GmbH Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:* Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.For further information please refer to section 5.1.
Clopidogrel Teva (hydrogen sulphate) clopidogrel hydrogen sulphate Teva Pharma B.V. Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Clopidogrel Teva Pharma (previously Clopidogrel HCS) clopidogrel hydrochloride Teva B.V.   Clopidogrel is indicated in:Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.For further information please refer to section 5.1.
Clopidogrel Zentiva (previously Clopidogrel Winthrop) clopidogrel Sanofi-aventis Prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.
Clopidogrel/Acetylsalicylic acid Teva clopidogrel / acetylsalicylic acid Teva Pharma B.V. Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Teva is a fixeddose combination medicinal product for continuation of therapy in: NonST segment elevation acute coronary syndrome (unstable angina or nonQwave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy
CoAprovel irbesartan / hydrochlorothiazide Sanofi Clir SNC Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Colobreathe colistimethate sodium Forest Laboratories UK Limited Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) agedsix years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Combivir lamivudine / zidovudine ViiV Healthcare UK Limited   Combivir is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.
Cometriq cabozantinib TMC Pharma Services Ltd Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Competact pioglitazone / metformin hydrochloride Takeda Pharma A/S Competact is indicated in the treatment of type-2-diabetes-mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Comtan entacapone Novartis Europharm Limited Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Comtess entacapone Orion Corporation Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Conbriza bazedoxifene Pfizer Ltd Conbriza is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established. When determining the choice of Conbriza or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.
Constella linaclotide Almirall S.A. Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.
Controloc Control pantoprazole Takeda GmbH Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Copalia amlodipine (as besylate) / valsartan Novartis Europharm Ltd Treatment of essential hypertension. Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Copalia HCT amlodipine / valsartan / hydrochlorothiazide Novartis Europharm Ltd. Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) levodopa / carbidopa / entacapone Orion Corporation Corbilta is indicated for the treatment of adult patients with Parkinsons disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Corlentor ivabradine hydrochloride Les Laboratoires Servier Treatment of coronary-artery disease Symptomatic treatment of chronic stable angina pectoris in coronary-artery-disease patients with normal sinus rhythm. Ivabradine is indicated: in patients unable to tolerate or with a contraindication to the use of beta-blockers; or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is 60 beats per minute (bpm). Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure New York Heart Association II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Cosentyx secukinumab Novartis Europharm Ltd Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Crixivan indinavir sulphate Merck Sharp & Dohme Ltd Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.
Cubicin daptomycin Novartis Europharm Limited Cubicin is indicated for the treatment of the following infections in adults. complicated skin and soft-tissue infections (cSSTI); right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice; Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI. Daptomycin is active against Gram-positive bacteria only. In mixed infections where Gram-negative and / or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Cuprymina copper (64Cu) chloride Sparkle S.r.l   Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Cyanokit hydroxocobalamin SERB SA Treatment of known or suspected cyanide poisoning. Cyanokit is to be administered together with appropriate decontamination and supportive measures.
Cymbalta duloxetine Eli Lilly Nederland B.V. Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Cymbalta is indicated in adults.
Cyramza ramucirumab Eli Lilly Nederland B.V. Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.
Cystadane betaine anhydrous Orphan Europe S.A.R.L. Adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS); 5,10-methylene-tetrahydrofolate reductase (MTHFR); cobalamin cofactor metabolism (cbl). Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
Cystagon mercaptamine bitartrate Orphan Europe S.A.R.L. Cystagon is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Dacogen decitabine Janssen-Cilag International N V   Treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.
Dafiro amlodipine / valsartan Novartis Europharm Ltd. Treatment of essential hypertension. Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Dafiro HCT amlodipine besylate / valsartan / hydrochlorothiazide Novartis Europharm Limited Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Daklinza daclatasvir dihydrochloride Bristol-Myers Squibb Pharma EEIG Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). For HCV genotype specific activity, see sections 4.4 and 5.1.
Daliresp roflumilast Takeda GmbH Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
Dasselta desloratadine Krka, d.d., Novo mesto Dasselta is indicated for the relief of symptoms associated with: allergic rhinitis (see section 5.1); urticaria (see section 5.1).
DaTSCAN ioflupane (123l) GE Healthcare Limited This medicinal product is for diagnostic use only. DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: In adult patients with clinically uncertain Parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinsons disease, multiple system atrophy and progressive supranuclear palsy. DaTSCAN is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy. In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimers disease. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinsons disease dementia.
Daxas roflumilast Takeda GmbH Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
Defitelio defibrotide Gentium SpA Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated in adults and in adolescents, children and infants over 1 month of age.
Deltyba delamanid Otsuka Novel Products GmbH Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
DepoCyte cytarabine Pacira Limited Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.
Desloratadine Actavis desloratadine Actavis Group PTC ehf Treatment of allergic rhinitis and urticaria
Desloratadine ratiopharm desloratadine ratiopharm GmbH Relief of symptoms associated with: allergic rhinitis; urticaria.
Desloratadine Teva desloratadine Teva B.V Desloratadine Teva is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.
Dexdor dexmedetomidine hydrochloride Orion Corporation For sedation of adultintensive care unit patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).
Diacomit stiripentol Biocodex Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.
Dificlir fidaxomicin Astellas Pharma Europe BV Dificlir is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD). Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Docetaxel Accord docetaxel Accord Healthcare Ltd Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Docetaxel Kabi docetaxel Fresenius Kabi Oncology Plc Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Docetaxel Teva docetaxel Teva B.V.   Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Docetaxel Winthrop docetaxel Aventis Pharma S.A. Breast cancer Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Duaklir Genuair aclidinium bromide / formoterol fumarate dihydrate AstraZeneca AB Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Duavive oestrogens conjugated / bazedoxifene Pfizer Limited Duavive is indicated for: Treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate. The experience treating women older than 65 years is limited.
Dukoral recombinant cholera toxin B subunit / vibrio cholerae 01 Crucell Sweden AB Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas. The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions. Dukoralshould not replace standard protective measures. In the event of diarrhoea measures of rehydration should be instituted.
Duloxetine Lilly duloxetine Eli Lilly Nederland B.V. Duloxetine Lilly is indicated in adults for: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Lilly is indicated in adults.
Duloxetine Mylan duloxetine Generics (UK) Limited Treatment of major depressive disorder; Treatment of diabetic peripheral neuropathic pain; Treatment of generalised anxiety disorder; Duloxetine Myl++an is indicated in adults. For further information see section 5.1.
DuoCover clopidogrel / acetylsalicylic acid Sanofi-aventis groupe DuoCover is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoCover is a fixed-dose combination medicinal product for continuation of therapy in: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention; ST-segment-elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy.
DuoPlavin clopidogrel / acetylsalicylic acid Sanofi Pharma Bristol-Myers Squibb SNC DuoPlavin is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention; ST-segment-elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy.
DuoResp Spiromax budesonide / formoterol fumarate dihydrate Teva Pharma B.V. DuoResp Spiromax is indicated in adults 18 years of age and older only. Asthma DuoResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting 2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and as needed inhaled short-acting 2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting 2 adrenoceptor agonists. Chronic obstructive pulmonary disease Symptomatic treatment of patients with severe chronic obstructive pulmonary disease - COPD (FEV1 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
DuoTrav travoprost / timolol Alcon Laboratories (UK) Ltd Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues (see section 5.1).
Dutrebis lamivudine / raltegravir potassium Merck Sharp & Dohme Limited Dutrebis is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV1) infection in adults, adolescents, and children from the age of 6years and weighing at least 30kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections4.2, 4.4 and 5.1).
Dynastat parecoxib sodium Pfizer Limited For the short-term treatment of postoperative pain in adults.
Ebilfumin oseltamivir Actavis Group PTC ehf Treatment of influenzaIn patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child. Prevention of influenzaPost-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). Ebilfumin is not a substitute for influenza vaccination.
Ebixa memantine hydrochloride H. Lundbeck A/S Treatment of patients with moderate to severe Alzheimer's disease.
Ecalta anidulafungin Pfizer Limited Treatment of invasive candidiasis in adult non-neutropenic patients. Ecalta has been studied primarily in patients with candidaemia and only in a limited number of patients with deep tissue Candida infections or with abscess-forming disease (see section 4.4 and section 5.1).
Ecansya (previously Capecitabine Krka) capecitabine Krka, d.d., Novo mesto Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes stage-C) colon cancer. Ecansya is indicated for the treatment of metastatic colorectal cancer. Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Ecansya in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Ecansya is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Edarbi azilsartan medoxomil Takeda Pharma A/S Edarbi is indicated for the treatment of essential hypertension in adults.
Edurant rilpivirine hydrochloride Janssen-Cilag International N.V.    Edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-nave adult patients with a viral load 100,000 HIV-1 RNA copies/ml. As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Edurant (see sections 4.4 and 5.1).
Efavirenz Teva efavirenz Teva B.V. Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older. Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.
Effentora fentanyl Teva B.V. Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Efficib sitagliptin / metformin hydrochloride Merck Sharp & Dohme Ltd For patients with type-2 diabetes mellitus: Efficib is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Efficib is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Efficib is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Efficib is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.
Efient prasugrel Eli Lilly Nederland B.V. Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI). For further information, please refer to section 5.1.
Eklira Genuair aclidinium bromide, micronised AstraZeneca AB Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Elaprase idursulfase Shire Human Genetic Therapies AB Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.
Eliquis apixaban Bristol-Myers Squibb / Pfizer EEIG Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip- or knee-replacement surgery.
ellaOne ulipristal Laboratoire HRA Pharma Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.
Elonva corifollitropin alfa Merck Sharp & Dohme Limited Controlled ovarian stimulation in combination with a gonadotrophin-releasing-hormone antagonist for the development of multiple follicles in women participating in an assisted-reproductive-technology programme.
Emadine emedastine Alcon Laboratories (UK) Ltd. Symptomatic treatment of seasonal allergic conjunctivitis.
Emend aprepitant Merck Sharp & Dohme Ltd. Emend 40 mg is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Emend 80 mg, 125 mg and 165 mg are indicated for prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. Emend 80 mg, 125 mg and 165 mg are given as part of combination therapy.
Emselex darifenacin hydrobromide Merus Labs Luxco S.à R.L. Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Emtriva emtricitabine Gilead Sciences International Ltd. Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens. When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.
Enbrel etanercept Pfizer Limited Rheumatoid arthritis Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis in children and adolescents from the age oftwo years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Enbrel has not been studied in children aged less thantwo years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age ofsix years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Entacapone Orion entacapone Orion Corporation Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Entacapone Teva entacapone Teva Pharma B.V. Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Entyvio vedolizumab Takeda Pharma A/S Ulcerative colitisEntyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF) antagonist. Crohns disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohns disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF) antagonist.
Enurev Breezhaler glycopyrronium bromide Novartis Europharm Ltd Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Envarsus tacrolimus Chiesi Farmaceutici S.p.A. Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Enyglid repaglinide Krka, d.d., Novo mesto Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Eperzan albiglutide GlaxoSmithKline Trading Services Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).
Epivir lamivudine ViiV Healthcare UK Limited   Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.
Epoetin Alfa Hexal epoetin alfa Hexal AG Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis (see section 4.4); Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (see section 4.4). Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Eporatio epoetin theta ratiopharm GmbH Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Erbitux cetuximab Merck KGaA Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck: in combination with radiation therapy for locally advanced disease; in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.
Erivedge vismodegib Roche Registration Ltd Treatment of advanced basal-cell carcinoma
Esbriet pirfenidone Roche Registration Limited Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis.
Esmya ulipristal acetate Gedeon Richter Ltd.   Ulipristal acetate is indicated for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Eucreas vildagliptin / metformin hydrochloride Novartis Europharm Ltd Eucreas is indicated in the treatment of type-2 diabetes mellitus: Eucreas is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. Eucreas is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea. Eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Eurartesim piperaquine tetraphosphate / dihydroartemisinin Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, children and infants 6 months and over and weighing 5 kg or more. Consideration should be given to official guidance on the appropriate use of antimalarial agents.
Evarrest human fibrinogen / human thrombin Omrix Biopharmaceuticals N. V. Evarrest is indicated in adults for supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.
Evicel human fibrinogen / human thrombin Omrix Biopharmaceuticals S.A. Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. Evicel is also indicated as suture support for haemostasis in vascular surgery.
Eviplera emtricitabine / rilpivirine hydrochloride /tenofovir disoproxil fumarate Gilead Sciences International Ltd   Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load 100,000 HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1). As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1).
Evista raloxifene hydrochloride Daiichi Sankyo Europe GmbH Evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Evoltra clofarabine Genzyme Europe B.V. Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients 21 years old at initial diagnosis.
Evotaz atazanavir sulfate / cobicistat Bristol-Myers Squibb Pharma EEIG Evotazis indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.
Evra norelgestromin / ethinyl estradiol Janssen-Cilag International NV Female contraception. Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
Exelon rivastigmine Novartis Europharm Ltd Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Exforge amlodipine (as besylate) / valsartan Novartis Europharm Ltd Treatment of essential hypertension. Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Exforge HCT amlodipine besylate / valsartan / hydrochlorothiazide Novartis Europharm Ltd Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Exjade deferasirox Novartis Europharm Limited Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions( 7 ml/kg/month of packed red blood cells)in patients with beta thalassaemia major agedsix years and older. Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in patients with beta thalassaemia major with iron overload due to frequent blood transfusions( 7 ml/kg/month of packed red blood cells)agedtwo tofive years; in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions ( 7 ml/kg/month of packed red blood cells) agedtwo years and older; in patients with other anaemias agedtwo years and older.
Extavia interferon beta-1b Novartis Europharm Limited Extavia is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Exviera dasabuvir sodium AbbVie Ltd Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Eylea aflibercept Bayer Pharma AG Eylea is indicated for adults for the treatment of: neovascular (wet) age-related macular degeneration (AMD); visual impairment due to macular oedema secondary toretinal vein occlusion (branch RVO or central RVO); visual impairment due to diabetic macular oedema (DME).
Fabrazyme agalsidase beta Genzyme Europe B.V. Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (-galactosidase-A deficiency).
Fampyra fampridine Biogen Idec Ltd   Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale 4-7).
Fareston toremifene Orion Corporation First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.Fareston is not recommended for patients with estrogen receptor negative tumours.
Faslodex fulvestrant AstraZeneca UK Ltd Faslodex is indicated for the treatment of post-menopausal women with oestrogen-receptor-positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen.
Fasturtec rasburicase Sanofi-aventis groupe   Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Fendrix hepatitis B surface antigen GlaxoSmithKline Biologicals S.A. Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
Ferriprox deferiprone Apotex Europe BV Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Fertavid follitropin beta Merck Sharp & Dohme Ltd. In the female: Fertavid is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Filgrastim Hexal filgrastim Hexal AG Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPCs). In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC 0.5 x 109/l), and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Firazyr icatibant Shire Orphan Therapies GmbH Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).
Firdapse (previously Zenas) amifampridine BioMarin Europe Ltd Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Firmagon degarelix Ferring Pharmaceuticals A/S Firmagon is a gonadotrophin-releasing-hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
Flebogamma DIF (previously Flebogammadif) human normal immunoglobulin Instituto Grifols S.A. Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barr syndrome; Kawasaki disease.
Fluenz Tetra influenza virus type A, H1N1 / influenza virus type A, H3N2 / influenza virus type B (Victoria lineage) / influenza virus, type B (Yamagata lineage) MedImmune LLC Prophylaxis of influenza in children and adolescents 24months to less than 18years of age. The use of Fluenz Tetra should be based on official recommendations.
Focetria Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181 7.5 microgragms per 0.5 ml dose Novartis Vaccines and Diagnostics S.r.l. Prophylaxis of influenza caused by A (H1N1v) 2009 virus. Focetria should be used in accordance with official guidance.
Foclivia influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1) Novartis Vaccines Influenza Srl   Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
Forsteo teriparatide Eli Lilly Nederland B.V. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Fortacin lidocaine / prilocaine Plethora Solutions Limited Treatment of primary premature ejaculation in adult men.
Forxiga dapagliflozin propanediol monohydrate AstraZeneca AB Forxiga is indicated in adults aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control as: monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance; add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Fosavance alendronic acid / colecalciferol Merck Sharp & Dohme Ltd Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Fosavance reduces the risk of vertebral and hip fractures.
Foscan temoporfin biolitec pharma Itd. Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.
Fuzeon enfuvirtide Roche Registration Ltd. Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.
Fycompa perampanel Eisai Europe Ltd Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy (see section 5.1).
Galvus vildagliptin Novartis Europharm Limited Vildagliptin is indicated in the treatment of type-2 diabetes mellitus in adults: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance; a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.
Ganfort bimatoprost / timolol Allergan Pharmaceuticals Ireland Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Gardasil human papillomavirus type 6 L1 protein / human papillomavirus type 11 L1 protein / human papillomavirus type 16 L1 protein / human papillomavirus type 18 L1 protein Sanofi Pasteur MSD, SNC Gardasil is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acuminata) causally related to specific HPV types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Gardasil should be in accordance with official recommendations.
Gardasil 9 human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) Sanofi Pasteur MSD Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases: Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types Genital warts (Condyloma acuminata) caused by specific HPV types. See sections 4.4 and 5.1 for important information on the data that support these indications. The use of Gardasil 9 should be in accordance with official recommendations.
Gazyvaro obinutuzumab Roche Registration Ltd Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy
Gilenya fingolimod hydrochloride Novartis Europharm Ltd Gilenya is indicated as single disease-modifying therapy in highly active relapsing-remitting multiple sclerosis for the following adult patient groups: patients with high disease activity despite treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of at least one disease modifying therapy. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion. A non-responder could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year; or: patients with rapidly evolving severe relapsing remitting multiple sclerosis defined bytwo or more disabling relapses in one year, and withone or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Giotrif afatinib Boehringer Ingelheim International GmbH Treatment of non-small-cell lung cancer (NSCLC) with epidermal-growth-factor-receptor (EGFR) mutation(s)
Glidipion (previously Pioglitazone Actavis Group) pioglitazone hydrochloride Actavis Group PTC ehf    Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with: metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Gliolan 5-aminolevulinic acid hydrochloride Medac GmbH Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (World Health Organization grade III and IV).
Glivec imatinib Novartis Europharm Ltd Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia-chromosome (bcr-abl)-positive (Ph+) chronic myeloid leukaemia (CML) for whom bone-marrow transplantation is not considered as the first line of treatment; adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis; adult and paediatric patients with newly diagnosed Philadelphia-chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ ALL as monotherapy; adult patients with myelodysplastic / myeloproliferative diseases (MDS / MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; adult patients with advanced hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRa rearrangement. The effect of Glivec on the outcome of bone-marrow transplantation has not been determined. Glivec is indicated for: the treatment of adult patients with Kit (CD 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (GIST); the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment; the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and / or metastatic DFSP who are not eligible for surgery. In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS / MPD, on haematological response rates in HES / CEL and on objective response rates in adult patients with unresectable and / or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Glivec in patients with MDS / MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Glubrava metformin hydrochloride / pioglitazone hydrochloride Takeda Pharma A/S Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. After initiation of therapy with pioglitazone, patients should be reviewed afterthree tosix months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Glustin pioglitazone hydrochloride Takeda Pharma A/S Pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. as dual oral therapy in combination with: metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with: metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). After initiation of therapy with pioglitazone, patients should be reviewed after three tosix months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Glybera alipogene tiparvovec uniQure biopharma B.V.   Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. The diagnosis of LPLD has to be confirmed by genetic testing. The indication is restricted to patients with detectable levels of LPL protein.
GONAL-f follitropin alfa Merck Serono Europe Ltd. Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate. Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in-vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level 1.2 IU/l. GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.
Granupas (previously Para-aminosalicylic acid Lucane) para-aminosalicylic acid Lucane Pharma Granupas is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Grastofil filgrastim Apotex Europe BV Grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Grastofil are similar in adults and children receiving cytotoxic chemotherapy. Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Grepid clopidogrel besilate Pharmathen S.A. Prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (fromseven days until less thansix months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonistsand who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Halaven eribulin Eisai Europe Ltd Halavenis indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
Harvoni sofosbuvir / ledipasvir Gilead Sciences International Ltd Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults.
HBVaxPro hepatitis B, recombinant surface antigen Sanofi Pasteur MSD SNC 5 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 10 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 40 micrograms HBVaxPro is indicated for the active immunisation against hepatitis-B-virus infection caused by all known subtypes in predialysis and dialysis adult patients. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Helicobacter Test INFAI 13C-urea INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: adults; adolescents, who are likely to have peptic ulcer disease. Helicobacter Test INFAI for children agedthree to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection: for the evaluation of the success of eradication treatment, or; when invasive tests cannot be performed, or; when there are discordant results arising from invasive tests. This medicinal product is for diagnostic use only.
Helixate NexGen octocog alfa Bayer Pharma AG   Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Hemangiol propranolol hydrochloride Pierre Fabre Dermatologie Hemangiol is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy:- Life- or function-threatening haemangioma,- Ulcerated haemangioma with pain and/or lack of response to simple wound care measures,-Haemangioma with a risk of permanent scars or disfigurement.It is to be initiated in infants aged 5 weeks to 5 months
Hepsera adefovir dipivoxil Gilead Sciences International Limited Hepsera is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section5.1); decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.
Herceptin trastuzumab Roche Registration Limited Breast cancer Metastatic breast cancer Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer: as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone-receptor-positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments; in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable; in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease; in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive metastatic breast cancer, not previously treated with trastuzumab. Early breast cancer Herceptin is indicated for the treatment of patients with HER2-positive early breast cancer: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable); following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin; in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours 2 cm in diameter. Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anticancer treatment for their metastatic disease. Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC3+ result. Accurate and validated assay methods should be used.
Hetlioz tasimelteon Vanda Pharmaceuticals Ltd Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Hexacima diphtheria toxoid /tetanus toxoid / two-component acellular pertussis(pertussis toxoidand filamentous haemagglutinin ) /inactivated poliomyelitis virus types 1,2 and 3 /Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein / hepatitis-B surface antigen Sanofi Pasteur S.A. Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilusinfluenzae type-b (Hib).
Hexyon diphtheria toxoid/ tetanus toxoid/ two-component acellular pertussis (pertussis toxoidand filamentous haemagglutinin)/ inactivated poliomyelitis virus types 1, 2 and 3 /Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein /hepatitis-B surface antigen Sanofi Pasteur MSD SNC Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilusinfluenzae type b (Hib).
Hirobriz Breezhaler indacaterol maleate Novartis Europharm Ltd Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.
Hizentra human normal immunoglobulin (SCIg) CSL Behring GmbH Replacement therapy in adults and children in primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiency; immunoglobulin-G-subclass deficiencies with recurrent infections; replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Holoclar ex vivo expanded autologous human corneal epithelial cells containing stem cells Chiesi Farmaceutici S.p.A. Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.
Humalog insulin lispro Eli Lilly Nederland B.V. For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.
Humira adalimumab AbbVie Ltd Spondylitis, Ankylosing Arthritis, Rheumatoid Colitis, Ulcerative Crohn Disease Arthritis, Psoriatic Psoriasis Arthritis, Juvenile Rheumatoid Paediatric plaque psoriasis
Hycamtin topotecan Novartis Europharm Limited Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
HyQvia human normal immunoglobulin Baxalta Innovations GmbH Replacement therapy in adults ( 18 years) in primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiency; IgG subclass deficiencies with recurrent infections. Replacement therapy in adults ( 18 years) in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Iasibon ibandronic acid Pharmathen S.A. Concentrate for solution for infusion:Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.Treatment of tumour-induced hypercalcaemia with or without metastases. Film-coated Tablets:Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Ibandronic acid Accord ibandronic acid Accord Healthcare Ltd Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour induced hypercalcaemia with or without metastases. Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Ibandronic Acid Sandoz ibandronic acid Sandoz GmbH Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Ibandronic Acid Teva ibandronic acid Teva Pharma B.V. Ibandronic acid 50mgIbandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Ibandronic acid 150mgTreatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established .
Icandra (previously Vildagliptin / metformin hydrochloride Novartis) vildagliptin / metformin hydrochloride Novartis Europharm Limited Icandra is indicated in the treatment of type-2 diabetes mellitus: Icandra is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. Icandra is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea. Icandra is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Iclusig ponatinib Ariad Pharma Ltd Iclusig is indicated in adult patients with: chronic-phase, accelerated-phase or blast-phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib, who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation; Philadelphia-chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib, who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation.
IDflu A/California/7/2009 (H1N1)pdm09-derived strain used (NYMC X-179A) A/Victoria/361/2011 (H3N2)-like strain used (NYMC X-223A) derived from A/Texas/50/2012 B/Massachusetts/02/2012 Sanofi Pasteur S.A. 9micrograms/strain Prophylaxis of influenza in adults up to 59 years of age, especially in those who run an increased risk of associated complications. The use of IDflu should be based on official recommendations. 15 micrograms/strain Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications. The use of IDflu should be based on official recommendations.
Ifirmacombi irbesartan / hydrochlorothiazide Krka, d.d., Novo mesto Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Ifirmasta (previously Irbesartan Krka) irbesartan hydrochloride Krka, d.d., Novo mesto Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 4.3, 4.4, 4.5 and 5.1).
Ikervis ciclosporin Santen Oy Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Ilaris canakinumab Novartis Europharm Ltd Cryopyrin-Associated Periodic Syndromes Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 2years and older with body weight of 7.5kg or above, including: Muckle-Wells Syndrome (MWS), Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), Severe forms of Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash. Systemic Juvenile Idiopathic Arthritis (SJIA) Ilaris is indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate. Gouty arthritis Ilaris is indicated for the symptomatic treatment of adults patients with frequent gouty arthritis attacks (at least 3attacks in the previous 12months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.
Imatinib Accord imatinib Accord Healthcare Ltd Imatinib Accord is indicated for the treatment of: paediatric patients with newly diagnosed Philadelphia-chromosome (bcr-abl)-positive (Ph+) chronic myeloid leukaemia (CML) for whom bone-marrow transplantation is not considered as the first line of treatment; paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis; adult patients with Ph+ CML in blast crisis; adult patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ ALL as monotherapy; adult patients with myelodysplastic / myeloproliferative diseases (MDS / MPD) associated with platelet-derived-growth-factor-receptor (PDGFR)-gene re-arrangements adult patients with advanced hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement; adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and / or metastatic DFSP who are not eligible for surgery.
Imatinib Actavis imatinib Actavis Group PTC ehf Imatinib Actavis is indicated for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult patients with Ph+ CML in blast crisis. adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. adult patients with relapsed or refractory Ph+ ALL as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery: The effect of imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Actavis is indicated for In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Imatinib medac imatinib Medac Imatinib medac is indicated for the treatment of: paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment; paediatric patients with Ph+CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase; adult and paediatric patients with Ph+CML in blast crisis; adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) integrated with chemotherapy; adult patients with relapsed or refractory Ph+ALL as monotherapy; adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement; adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. The effect of imatinib on the outcome of bone marrow transplantation has not been determined. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Imatinib Teva imatinib Teva B.V. Imatinib Teva is indicated for the treatment of: paediatric patients with newly diagnosed Philadelphia-chromosome (bcr-abl)-positive (Ph+) chronic myeloid leukaemia (CML) for whom bone-marrow transplantation is not considered as the first line of treatment; paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis; adult patients with Ph+ CML in blast crisis. The effect of imatinib on the outcome of bone-marrow transplantation has not been determined. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML.
Imbruvica ibrutinib Janssen-Cilag International NV Imbruvica is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).Imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo immunotherapy.Imbruvica is indicated for the treatment of adult patients with Waldenstrms macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy.
Imnovid (previously Pomalidomide Celgene) pomalidomide Celgene Europe Ltd Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Imprida amlodipine (as besylate) / valsartan Novartis Europharm Ltd Treatment of essential hypertension. Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Imvanex modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus Bavarian Nordic A/S Active immunisation against smallpox infection and disease in adults.
Incivo telaprevir Janssen-Cilag International N.V. Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): who are treatment nave; who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.
Increlex mecasermin Ipsen Pharma For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD). Severe primary IGFD is defined by: height standard deviation score -3.0 and; basal insulin-like growth factor-1 (IGF-1)levels below the 2.5th percentile for age and gender and; growth hormone (GH)sufficiency; exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.
Incresync alogliptin / pioglitazone Takeda Pharma A/S Incresync is indicated as a second- or third-line treatment in adult patients aged 18years and older with type-2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance; in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18years and older with type-2 diabetes mellitus already being treated with this combination. After initiation of therapy with Incresync, patients should be reviewed afterthreetosixmonths to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section4.4).
Incruse umeclidinium bromide Glaxo Group Ltd Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Inductos dibotermin alfa Medtronic BioPharma B.V. Inductos is indicated for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non operative treatment for this condition. Inductos is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Infanrix Hexa diphtheria toxoid / tetanus toxoid / Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) / hepatitis B surface antigen / poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)) / Haemophilus influenzae type-b polysaccharide GlaxoSmithKline Biologicals S.A. Infanrix Hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type-b.
Inflectra infliximab Hospira UK Limited Rheumatoid arthritis Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to diseasemodifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by Xray, has been demonstrated. Adult Crohns disease Inflectra is indicated for: treatment of moderately to severely active Crohns disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies; treatment of fistulising, active Crohns disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohns disease Inflectra is indicated for treatment of severe, active Crohns disease in children and adolescents agedsix to 17years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents agedsix to 17years, who have had an inadequate response to conventional therapy including corticosteroids and 6MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Inflectra is indicated for treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Inflectra should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by Xray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).
Inlyta axitinib Pfizer Ltd   Inlyta is indicated for the treatment of adult patients with advanced renal-cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
INOmax nitric oxide Linde Healthcare AB INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
Inovelon rufinamide Eisai Ltd Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patientsfour years and older.
Instanyl fentanyl citrate Takeda Pharma A/S Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Insulatard insulin human Novo Nordisk A/S Treatment of diabetes mellitus.
Insulin Human Winthrop insulin human Sanofi-aventis Deutschland GmbH Diabetes mellitus where treatment with insulin is required. Insulin Human Winthrop Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.
Insuman insulin human Sanofi-aventis Deutschland GmbH Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.
Intanza A/California/7/2009 (H1N1)pdm09-derived strainA/Victoria/361/2011 (H3N2)-like strainB/Massachusetts/02/2012 Sanofi Pasteur MSD, SNC 9 micrograms/strain Prophylaxis of influenza in adults up to 59 years of age, especially in those who run an increased risk of associated complications. The use of Intanza should be based on official recommendations. 15 micrograms/strain Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications. The use of Intanza should be based on official recommendations.
Integrilin eptifibatide Glaxo Group Ltd Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin. Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes. Patients most likely to benefit from Integrilin treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early percutaneous transluminal coronary angioplasty (PTCA) (see section 5.1).
Intelence etravirine Janssen-Cilag International NV Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients fromsix years of age. This indication is based on week-48 analyses fromtwo phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen(OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.
IntronA interferon alfa-2b Merck Sharp & Dohme Limited Chronic hepatitis B Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication (presence of DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis. Chronic hepatitis C Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon (see section 5.1). Adult patients IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis-C virus-RNA (HCV-RNA) (see section 4.4). The best way to use IntronA in this indication is in combination with ribavirin. Childrenthree years of age and older and adolescents IntronA is indicated, in a combination regimen with ribavirin, for the treatment of childrenthree years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients. The decision to treat should be made on a case-by-case basis (see section 4.4). Hairy-cell leukaemia Treatment of patients with hairy cell leukaemia. Chronic myelogenous leukaemia Monotherapy Treatment of adult patients with Philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia. Clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is 34 %, but 90 % Ph+ cells in the marrow. Combination therapy The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy. Multiple myeloma As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy. Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated. Follicular lymphoma Treatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen. High tumour burden is defined as having at least one of the following: bulky tumour mass ( 7 cm), involvement of three or more nodal sites (each 3 cm), systemic symptoms (weight loss 10 %, pyrexia 38C for more thaneight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia. Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'. Malignant melanoma As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node...
Invanz ertapenem sodium Merck Sharp & Dohme Ltd. Treatment Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required: intra-abdominal infections; community-acquired pneumonia; acute gynaecological infections; diabetic foot infections of the skin and soft tissue. Prevention Invanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Invega paliperidone Janssen-Cilag International NV Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older. Invega is indicated for the treatment of schizoaffective disorder in adults.
Invirase saquinavir Roche Registration Ltd. Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.
Invokana canagliflozin Janssen-Cilag International N.V. Invokana is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. Add on therapy Add on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add on therapies).
Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) irbesartan / hydrochlorothiazide sanofi-aventis groupe   Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Irbesartan Teva irbesartan Teva B.V. Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).
Irbesartan Zentiva (previously Irbesartan Winthrop) irbesartan Sanofi-aventis groupe   Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.
Irbesartan/Hydrochlorothiazide Teva irbesartan / hydrochlorothiazide Teva B.V.   Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Iressa gefitinib AstraZeneca AB Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancerwith activating mutations of epidermal-growth-factor-receptor tyrosine kinase (see section 5.1).
Iscover clopidogrel Sanofi-aventis groupe Prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (fromseven days until less thansix months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation. In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists (VKAs) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Isentress raltegravir Merck Sharp & Dohme Ltd Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1)infection in adults, adolescents, children, toddlers and infants from the age of 4 weeks.
Ivemend fosaprepitant Merck Sharp & Dohme Ltd Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy in adults. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. Ivemend 115 mg is given as part of a combination therapy.
Ixiaro Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells) Valneva Austria GmbH Ixiaro is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants agedtwo months and older. Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.
Izba travoprost Alcon Laboratories (UK) Ltd Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma
Jakavi ruxolitinib (as phosphate) Novartis Europharm Ltd Treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythaemia-vera myelofibrosis or post-essential-thrombocythaemia myelofibrosis.
Jalra vildagliptin Novartis Europharm Ltd Vildagliptin is indicated in the treatment of type-2 diabetes mellitus in adults: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance; a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.
Janumet sitagliptin / metformin hydrochloride Merck Sharp & Dohme Ltd For patients with type-2 diabetes mellitus: Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Janumet is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Janumet is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Janumet is also indicated as add on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.
Januvia sitagliptin Merck Sharp & Dohme Ltd For adult patients with type-2 diabetes mellitus, Januvia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome-proliferator-activated-receptor-gamma (PPAR) agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control; aPPAR agonist (i.e. a thiazolidinedione) when use of aPPAR agonist is appropriate and when diet and exercise plus thePPAR agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Jardiance empagliflozin Boehringer Ingelheim International GmbH Jardiance is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as:MonotherapyWhen diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.Add-on combination therapyIn combination with other glucoselowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Javlor vinflunine Pierre Fabre Médicament Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status 2.
Jentadueto linagliptin / metformin Boehringer Ingelheim International GmbH Treatment of adult patients with type-2 diabetes mellitus: Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Jetrea ocriplasmin ThromboGenics NV Jetrea is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
Jevtana cabazitaxel sanofi-aventis groupe   Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
Jinarc tolvaptan Otsuka Pharmaceutical Europe Ltd Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.
Kadcyla trastuzumab emtansine Roche Registration Ltd Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for locally advanced or metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant therapy.
Kaletra lopinavir / ritonavir AbbVie Ltd Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human-immunodeficiency-virus (HIV-1)-infected adults, adolescents and children above the age oftwo years.The choice of Kaletra to treat protease-inhibitor-experienced HIV-1-infected patients should be based on individual viral resistance testing and treatment history of patients.
Kalydeco ivacaftor Vertex Pharmaceuticals (U.K.) Ltd Kalydeco is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R (see sections 4.4 and 5.1).
Karvea irbesartan Sanofi-aventis groupe Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Karvezide irbesartan / hydrochlorothiazide Sanofi-aventis groupe Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Kengrexal cangrelor The Medicines Company UK Ltd Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.
Kentera (previously Oxybutynin Nicobrand) oxybutynin Nicobrand Ltd. Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.
Kepivance palifermin Swedish Orphan Biovitrum AB (publ) Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.
Keppra levetiracetam UCB Pharma SA Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Keppra is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants fromone month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Ketek telithromycin Aventis Pharma S.A. When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance. Ketek is indicated for the treatment of the following infections: In patients of 18 years and older: community-acquired pneumonia, mild or moderate. when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin: acute exacerbation of chronic bronchitis; acute sinusitis; In patients of 12 years and older: tonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA.
Ketoconazole HRA ketoconazole Laboratoire HRA Pharma Ketoconazole HRA is indicated for the treatment of endogenous Cushings syndrome in adults and adolescents above the age of 12 years.
Keytruda pembrolizumab Merck Sharp & Dohme Limited Keytruda as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Kineret anakinra Biovitrum AB (publ) Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in adults with an inadequate response to methotrexate alone.
Kinzalkomb telmisartan / hydrochlorothiazide Bayer Pharma AG Treatment of essential hypertension. Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) telmisartan Bayer Pharma AG Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.
Kiovig human normal immunoglobulin (IVIg) Baxter AG Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS and recurrent bacterial infections. Immunomodulation in adults, and children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barr syndrome; Kawasaki disease; multifocal motor neuropathy (MMN).
Kivexa abacavir / lamivudine ViiV Healthcare UK Limited  Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.
Kogenate Bayer octocog alfa Bayer Pharma AG Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Komboglyze metformin hydrochloride /saxagliptin hydrochloride AstraZeneca AB  Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.
Krystexxa pegloticase Crealta Pharmaceuticals Ireland Limited Krystexxa is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
Kuvan sapropterin dihydrochloride Merck Serono Europe Limited Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment (see section 4.2).Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment (see section 4.2).
Lamivudine Teva lamivudine Teva B.V. Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).
Lamivudine Teva Pharma B.V. lamivudine Teva B.V.   Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.
Lamivudine/Zidovudine Teva lamivudine / zidovudine Teva Pharma B.V.   Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.
Lantus insulin glargine sanofi-aventis Deutschland GmbH Treatment of diabetes mellitus in adults, adolescents and children agedtwo years and above
Latuda lurasidone Takeda Pharma A/S Treatment of schizophrenia in adults aged 18 years and over.
Laventair umeclidinium bromide / vilanterol Glaxo Group Ltd Laventair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Leflunomide medac leflunomide medac Gesellschaft für klinische Spezialpräparate mbH Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD). Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Leflunomide ratiopharm leflunomide ratiopharm GmbH Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Leflunomide Winthrop leflunomide Sanofi-Aventis Deutschland GmbH Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Leganto rotigotine UCB Manufacturing Ireland Ltd   Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults. Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinsons disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or on-off fluctuations).
Lemtrada alemtuzumab Genzyme Therapeutics Ltd Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Lenvima lenvatinib mesylate Eisai Europe Ltd Lenvima is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hrthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
LeukoScan sulesomab Immunomedics GmbH This medicinal product is for diagnostic use only. LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers. LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Levemir insulin detemir Novo Nordisk A/S Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Levetiracetam Accord levetiracetam Accord Healthcare Ltd Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Levetiracetam Actavis levetiracetam Actavis Group PTC ehf Levetiracetam Actavis is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants fromone month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Levetiracetam Actavis Group levetiracetam Actavis Group PTC ehf Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis Group is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Levetiracetam Hospira levetiracetam Hospira UK Limited Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
Levetiracetam ratiopharm levetiracetam ratiopharm GmbH      Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam ratiopharm is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Levetiracetam Sun levetiracetam Sun Pharmaceutical Industries Europe B.V. Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Sun is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults and children fromfour years of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. Levetiracetam Sun concentrateis an alternative for patients when oral administration is temporarily not feasible.
Levetiracetam Teva levetiracetam Teva B.V. Levetiracetam Teva is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Teva is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Levitra vardenafil Bayer Pharma AG Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Levitra to be effective, sexual stimulation is required. Levitra is not indicated for use by women.
Levodopa/Carbidopa/Entacapone Orion levodopa / carbidopa / entacapone Orion Corporation Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
Libertek roflumilast Takeda GmbH Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
Liprolog insulin lispro Eli Lilly Nederland B.V. For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.
Litak cladribine Lipomed GmbH Litak is indicated for the treatment of hairy-cell leukaemia.
Lixiana edoxaban tosylate Daiichi Sankyo Europe GmbH Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Lojuxta lomitapide Aegerion Pharmaceuticals Lojuxta is indicated as an adjunct to a lowfat diet and other lipidlowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.
Lonquex lipegfilgrastim Sicor Biotech UAB Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Lucentis ranibizumab Novartis Europharm Ltd Lucentis is indicated in adults for: the treatment of neovascular (wet) age-related macular degeneration (AMD); the treatment of visual impairment due to diabetic macular oedema (DME); the treatment of visual impairment due to macular oedema secondary to retinal-vein occlusion (branch RVO or central RVO); the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM).
Lumark lutetium, isotope of mass 177 I.D.B. Radiopharmacy B.V. Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Lumigan bimatoprost Allergan Pharmaceuticals Ireland Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).
Luminity perflutren Lantheus MI UK Ltd. This medicinal product is for diagnostic use only. Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Luveris lutropin alfa Merck Serono Europe Ltd. Luveris in association with a follicle-stimulating-hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe luteinising-hormone (LH) and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level 1.2 IU/l.
Lymphoseek tilmanocept Navidea Biopharmaceuticals Limited This medicinal product is for diagnostic use only. Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device.
Lynparza olaparib AstraZeneca AB Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Lyrica pregabalin Pfizer Limited Neuropathic pain Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Lyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Lysodren mitotane Laboratoire HRA Pharma Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.
Lyxumia lixisenatide Sanofi-Aventis Groupe Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations)
M-M-RVAXPRO measles virus Enders Edmonston strain (live, attenuated) / mumps virus Jeryl Lynn (level B) strain (live, attenuated) / rubella virus Wistar RA 27/3 strain (live, attenuated) Sanofi Pasteur MSD SNC M-M-RVAXPRO is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months or older. For use in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella.
MabThera rituximab Roche Registration Ltd MabThera is indicated in adults for the following indications: Non-Hodgkin's lymphoma MabThera is indicated for the treatment of previously untreated patients with stage-III-IV follicular lymphoma in combination with chemotherapy. MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. MabThera monotherapy is indicated for treatment of patients with stage-III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. MabThera is indicated for the treatment of patients with CD20-positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed / refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy. Rheumatoid arthritis MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying antirheumatic drugs (DMARDs) including one or more tumour-necrosis-factor (TNF)-inhibitor therapies. MabThera has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Macugen pegaptanib PharmaSwiss Ceska Republika s.r.o Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) (see section 5.1).
Marixino (previously Maruxa) memantine hydrochloride Consilient Health Ltd Treatment of patients with moderate to severe Alzheimers disease.
Matever levetiracetam Pharmathen S.A. Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Matever is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants fromone month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Mekinist trametinib Novartis Europharm Limited Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
Memantine Accord memantine hydrochloride Accord Healthcare Limited Treatment of patients with moderate to severe Alzheimers disease.
Memantine LEK memantine hydrochloride Pharmathen S.A. Treatment of patients with moderate to severe Alzheimers disease.
Memantine Merz memantine hydrochloride Merz Pharmaceuticals GmbH   Treatment of patients with moderate to severe Alzheimers disease.
Memantine Mylan memantine hydrochloride Generics [UK] Limited Treatment of patients with moderate to severe Alzheimers disease.
Memantine ratiopharm memantine hydrochloride Ratiopharm GmbH Treatment of patients with moderate to severe Alzheimers disease
Menveo meningococcal group A, C, W-135 and Y conjugate vaccine Novartis Vaccines and Diagnostics S.r.l. Prefilled syringe Menveo is indicated for active immunisation of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations. Vials Menveo is indicated for active immunisation of children (fromtwo years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in accordance with official recommendations.
Mepact mifamurtide Takeda France SAS Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patientstwo to 30 years of age at initial diagnosis.
Metalyse tenecteplase Boehringer Ingelheim International GmbH Metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left-bundle-branch block withinsix hours after the onset of acute-myocardial-infarction symptoms.
Methylthioninium chloride Proveblue methylthioninium chloride Provepharm S.A.S. Acute symptomatic treatment of medicinal and chemical product-induced methaemoglobinaemia.Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).
Micardis telmisartan Boehringer Ingelheim International GmbH Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.
MicardisPlus telmisartan / hydrochlorothiazide Boehringer Ingelheim International GmbH Treatment of essential hypertension. MicardisPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. MicardisPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on MicardisPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Mimpara cinacalcet Amgen Europe B.V. Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and / or vitamin-D sterols, as appropriate. Reduction of hypercalcaemia in patients with: parathyroid carcinoma; primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Mirapexin pramipexole dihydrochloride monohydrate Boehringer Ingelheim International GmbH Mirapexin is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).
Mircera methoxy polyethylene glycol-epoetin beta Roche Registration Ltd. Treatment of symptomatic anaemia associated with chronic kidney disease (CKD). The safety and efficacy of Mircera therapy in other indications has not been established.
Mirvaso brimonidine tartrate Galderma International Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.
Mixtard insulin human Novo Nordisk A/S Treatment of diabetes mellitus.
Modigraf tacrolimus Astellas Pharma Europe B.V. Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Moventig naloxegol oxalate AstraZeneca AB Treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s)
Mozobil plerixafor Genzyme Europe B.V. Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly (see section 4.2).
Multaq dronedarone sanofi-aventis groupe Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, Multaq should only be prescribed after alternative treatment options have been considered. Multaq should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
Mycamine micafungin Astellas Pharma Europe B.V. Mycamine is indicated for: adults, adolescents 16 years of age and elderly: treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count 500 cells/l) for 10 or more days; children (including neonates) and adolescents 16 years of age: treatment of invasive candidiasis. prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count 500 cells/l) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.
Myclausen mycophenolate mofetil Herbert J. Passauer GmbH & Co. KG Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Mycophenolate mofetil Teva mycophenolate mofetil Teva Pharma B.V. Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Myfenax mycophenolate mofetil Teva B.V. Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Myocet doxorubicin hydrochloride Teva B.V. Myocet, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.
Myozyme alglucosidase alfa Genzyme Europe B.V. Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid--glucosidase deficiency). In patients with late-onset Pompe disease the evidence of efficacy is limited.
Mysimba bupropion hydrochloride / naltrexone hydrochloride Orexigen Therapeutics Ireland Limited Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (18 years) with an initial Body Mass Index (BMI) of 30 kg/m2 (obese), or 27 kg/m2 to 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight (see Section 5.1).
Naglazyme galsulfase BioMarin Europe Ltd. Naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine-4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. A key issue is to treat young patients aged 5 years suffering from a severe form of the disease, even though patients 5 years were not included in the pivotal phase-3 study.
Nemdatine memantine Actavis Group PTC ehf. Treatment of patients with moderate to severe Alzheimers disease
Neoclarityn desloratadine Merck Sharp & Dohme Ltd   Neoclarityn is indicated for the relief of symptoms associated with: allergic rhinitis urticaria
NeoRecormon epoetin beta Roche Registration Ltd. Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients. Treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy. Increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Neulasta pegfilgrastim Amgen Europe B.V. Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Neupro rotigotine UCB Manufacturing Ireland Ltd Parkinson's disease:Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations).Restless-legs syndrome:Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.
Neuraceq florbetaben (18F) Piramal Imaging Limited This medicinal product is for diagnostic use only. Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimers disease (AD) and other causes of cognitive impairment. Neuraceq should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.
NeuroBloc botulinum toxin type B Eisai Ltd. NeuroBloc is indicated for the treatment of cervical dystonia (torticollis). See section 5.1 for data on efficacy in patients responsive / resistant to botulinum toxin type A.
Nevanac nepafenac Alcon Laboratories (UK) Ltd Nevanac is indicated for: prevention and treatment of postoperative pain and inflammation associated with cataract surgery; reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.
Nevirapine Teva nevirapine Teva B.V.   Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV 1 infected adults, adolescents, and children of any age. Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing.
Nexavar sorafenib Bayer Pharma AG Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hrthle cell) thyroid carcinoma, refractory to radioactive iodine.
Nexium Control esomeprazole Pfizer Consumer Healthcare Ltd Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.
NexoBrid concentrate of proteolytic enzymes enriched in bromelain MediWound Germany GmbH NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.
Nimenrix Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid /Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid GlaxoSmithKline Biologicals S.A. Nimenrix is indicated for active immunisation of individuals from the age of 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
Nimvastid rivastigmine Krka, d.d., Novo mesto Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Nivestim filgrastim Hospira UK Ltd.   Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Filgrastim is indicated for the treatment of persistent neutropenia (ANC 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Nivolumab BMS nivolumab Bristol-Myers Squibb Pharma EEIG Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Nonafact human coagulation factor IX Sanquin Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Norvir ritonavir AbbVie Ltd Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children oftwo years of age and older).
NovoEight turoctocog alfa Novo Nordisk A/S Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.
NovoMix insulin aspart Novo Nordisk A/S Treatment of diabetes mellitus.
NovoNorm repaglinide Novo Nordisk A/S Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
NovoRapid insulin aspart Novo Nordisk A/S Treatment of diabetes mellitus in adults, adolescents and children agedtwo years and above.
NovoSeven eptacog alfa (activated) Novo Nordisk A/S NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX 5 Bethesda units (BU); in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration; in patients with acquired haemophilia; in patients with congenital factor-VII deficiency; in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions.
NovoThirteen catridecacog Novo Nordisk A/S Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.
Noxafil posaconazole Merck Sharp & Dohme Ltd Noxafil is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products; oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Noxafil is also indicated for prophylaxis of invasive fungal infections in the following patients: patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; haematopoietic-stem-cell-transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft-versus-host disease and who are at high risk of developing invasive fungal infections.
Nplate romiplostim Amgen Europe B.V. Nplate is indicated for adult chronic-immune (idiopathic)-thrombocytopenic-purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate may be considered as second-line treatment for adult non-splenectomised patients where surgery is contra-indicated.
Nuedexta dextromethorphan / quinidine Jenson Pharmaceutical Services Limited Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4). Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.
Nulojix belatacept Bristol-Myers Squibb Pharma EEIG Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejectionin adults receiving a renal transplant (see section 5.1 for data on renal function). It is recommended to add an interleukin (IL)-2-receptor antagonist for induction therapy to this belatacept-based regimen.
NutropinAq somatropin Ipsen Pharma Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. Long-term treatment of growth failure associated with Turner syndrome. Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment.
Nuwiq simoctocog alfa Octapharma AB Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Nuwiq can be used for all age groups.
Ofev nintedanib Boehringer Ingelheim International GmbH Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Olanzapine Apotex olanzapine Apotex Europe B.V.   Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Olanzapine Glenmark olanzapine Glenmark Pharmaceuticals Europe Limited Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Olanzapine Glenmark Europe olanzapine Glenmark Pharmaceuticals Europe Limited   Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Olanzapine Mylan olanzapine Generics [UK] Ltd. Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Olanzapine Teva olanzapine Teva Pharma Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Olazax olanzapine Glenmark Pharmaceuticals s.r.o.   Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Olazax Disperzi olanzapine Glenmark Pharmaceuticals s.r.o.   Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Olysio simeprevir Janssen-Cilag International N.V. Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Omnitrope somatropin Sandoz GmbH Infants, children and adolescents Growth disturbance due to insufficient secretion of growth hormone (GH). Growth disturbance associated with Turner syndrome. Growth disturbance associated with chronic renal insufficiency. Growth disturbance (current height standard-deviation score (SDS) -2.5 and parental adjusted SDS -1) in short children / adolescents born small for gestational age (SGA), with a birth weight and / or length below -2 standard deviations (SDs), who failed to show catch-up growth (height velocity (HV) SDS 0 during the last year) byfour years of age or later. Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing. Adults Replacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (SDS -2) who may be considered for one test. The cut-off point of the dynamic test should be strict.
Onbrez Breezhaler indacaterol maleate Novartis Europharm Ltd. Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.
Onglyza saxagliptin AstraZeneca AB Add-on combination therapy Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate; as triple oral therapy: in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control; as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Opatanol olopatadine hydrochloride Alcon Laboratories (UK) Ltd Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Opdivo nivolumab Bristol-Myers Squibb Pharma EEIG Opdivo as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Opgenra eptotermin alfa Olympus Biotech International Limited Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Oprymea pramipexole dihydrochloride monohydrate Krka, d.d., Novo mesto Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).
Opsumit macitentan Actelion Registration Ltd Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Optaflu Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/California/7/2009 (H1N1)pdm09 - like strain used A/Brisbane/10/2010 wild type Victoria/361/2011 (H3N2) - like strain used (NYMC X-223A) derived from A/Texas/50/2012 B/Massachusetts/2/2012 Novartis Influenza Vaccines Marburg GmbH Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications. Optaflu should be used in accordance to official guidance.
Optimark gadoversetamide Mallinckrodt Deutschland GmbH This medicinal product is for diagnostic use only. Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.
Optison perflutren GE Healthcare AS This medicinal product is for diagnostic use only. Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation. Optison should only be used in patients where the study without contrast enhancement is inconclusive.
Optruma raloxifene hydrochloride Eli Lilly Nederland B.V. Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Orbactiv oritavancin diphosphate The Medicines Company UK Ltd Orbactiv is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Orencia abatacept Bristol-Myers Squibb Pharma EEIG Rheumatoid arthritis Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) including methotrexateor a tumour-necrosis-factor (TNF)-alfa inhibitor. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate. Polyarticular juvenile idiopathic arthritis Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritisin paediatric patientssix years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor.
Orfadin nitisinone Swedish Orphan Biovitrum International AB Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.
Orgalutran ganirelix Merck Sharp & Dohme Limited The prevention of premature luteinising-hormonesurges in women undergoing controlled ovarian hyperstimulationfor assisted reproduction techniques. In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.
Orphacol cholic acid Laboratoires CTRS Orphacol is indicated for the treatment of inborn errors in primary bile-acid synthesis due to 3-hydroxy-5-C27-steroid oxidoreductase deficiency or 4-3-oxosteroid-5-reductase deficiency in infants, children and adolescents agedone month to 18 years and adults.
Osigraft eptotermin alfa Olympus Biotech International Limited Treatment of nonunion of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.
Oslif Breezhaler indacaterol maleate Novartis Europharm Ltd.   Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.
Osseor strontium ranelate Les Laboratoires Servier Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures. Treatment of severe osteoporosis in adult men at increased risk of fracture. The decision to prescribe strontium ranelateshould be based on an assessment of the individual patient's overall risks.
Otezla apremilast Celgene Europe Limited Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Ovaleap follitropin alfa Teva Pharma B.V. In adult women Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate. Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy. Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy. In adult men Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level 1.2 IU/L.
Ovitrelle choriogonadotropin alfa Merck Serono Europe Limited Ovitrelle is indicated in the treatment of: women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth; anovulatory or oligo-ovulatory women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.
Ozurdex dexamethasone Allergan Pharmaceuticals Ireland Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO) (see section 5.1). Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis. Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
Paglitaz pioglitazone hydrochloride Krka, d.d., Novo mesto Pioglitazone is indicated as second or third line treatment of type2 diabetes mellitus as described below: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance; as dual oral therapy in combination with metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea; as triple oral therapy in combination with metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Paliperidone Janssen paliperidone palmitate Janssen-Cilag International NV Paliperidone Janssen is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Paliperidone Janssen may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Pandemic Influenza Vaccine H5N1 Baxter AG influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004(H5N1V) Baxter AG Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
Pandemrix split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A GlaxoSmithKline Biologicals S.A. Prophylaxis of influenza caused by A (H1N1)v 2009 virus. In persons under 20 years of age, Pandemrix should only be used if the recommended annual seasonal trivalent influenza vaccine is not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8). Pandemrix should be used in accordance with official guidance.
Panretin alitretinoin Eisai Ltd Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when: lesions are not ulcerated or lymphoedematous, and; treatment of visceral KS is not required, and; lesions are not responding to systemic antiretroviral therapy, and; radiotherapy or chemotherapy are not appropriate.
Pantecta Control pantoprazole Takeda GmbH Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Pantoloc Control pantoprazole Takeda GmbH Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Pantozol Control pantoprazole Takeda GmbH Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
PecFent fentanyl Archimedes Development Ltd PecFent is indicated for the management of breakthrough painin adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.
Pedea ibuprofen Orphan Europe S.A.R.L. Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Pegasys peginterferon alfa-2a Roche Registration Limited Chronic hepatitis B Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1). Chronic hepatitis C Adult patientsPegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1. Paediatric patients 5 years of age and olderPegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-nave children and adolescents 5 years of age and older who are positive for serum HCV-RNA. When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).
PegIntron peginterferon alfa-2b Merck Sharp & Dohme Limited   Adults (tritherapy) PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when PegIntron is to be used in combination with these medicines. Adults (bitherapy and monotherapy) PegIntron is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. PegIntron in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy. Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin. Please refer to the ribavirin SmPC when PegIntron is to be used in combination with ribavirin. Paediatric population (bitherapy) PegIntron is indicated in a combination regimen with ribavirin for the treatment of childrenthree years of age and older and adolescents who haveCHC, previously untreated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis. Please refer to the ribavirin SmPC for capsules or oral solution when PegIntron is to be used in combination with ribavirin.
Pergoveris follitropin alfa /lutropin alfa Merck Serono Europe Ltd. Pergoveris is indicated for the stimulation of follicular development in women with severe luteinising-hormone (LH)and follicle-stimulating-hormone deficiency.In clinical trials, these patients were defined by an endogenous serum LH level 1.2 IU/l.
Perjeta pertuzumab Roche Registration Limited Metastatic Breast Cancer:Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.Neoadjuvant Treatment of Breast Cancer:Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
Peyona (previously Nymusa) caffeine citrate Chiesi Farmaceutici SpA Treatment of primary apnoea of premature newborns.
Pheburane sodium phenylbutyrate Lucane Pharma Treatment of chronic management of urea-cycle disorders.
Picato ingenol mebutate LEO Pharma A/S Picato is indicated for the cutaneous treatment of nonhyperkeratotic, nonhypertrophic actinic keratosis in adults.
Pioglitazone Accord pioglitazone hydrochloride Accord Healthcare Ltd Pioglitazone is indicated in the treatment of type-2 diabetes mellitus: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone Actavis pioglitazone hydrochloride Actavis Group PTC ehf   Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Pioglitazone Teva pioglitazone hydrochloride Teva B.V. Pioglitazone is indicated in the treatment of type 2 diabetes mellitus: as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea as triple oral therapy in combination with- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.
Pioglitazone Teva Pharma pioglitazone hydrochloride Teva Pharma B.V. Pioglitazone is indicated in the treatment of type 2 diabetes mellitus: as monotherapy: - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4). After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Pixuvri pixantrone dimaleate CTI Life Sciences Limited Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.
Plavix clopidogrel hydrogen sulfate Sanofi Clir SNC Prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (fromseven days until less thansix months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Plegridy peginterferon beta-1a Biogen Idec Ltd Treatment of relapsing remitting multiple sclerosis in adult patients
Plenadren hydrocortisone ViroPharma SPRL Treatment of adrenal insufficiency in adults.
Potactasol topotecan Actavis Group PTC ehf Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with thefirst-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.
Pradaxa dabigatran etexilate mesilate Boehringer Ingelheim International GmbH Primary prevention of venous thromboembolic events in adult patients who have undergone elective total-hip-replacement surgery or total-knee-replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more of the following risk factors: previous stroke, transient ischaemic attack or systemic embolism; left ventricular ejection fraction 40%; symptomatic heart failure New York Heart Association (NYHA) class 2; age 75 years; age 65 years associated with one of the following: diabetes mellitus, coronary artery disease or hypertension.
Pramipexole Accord pramipexole dihydrochloride monohydrate Accord Healthcare Ltd Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).
Pramipexole Teva pramipexole dihydrochloride monohydrate Teva Pharma B.V. Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).
Prandin repaglinide Novo Nordisk A/S Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Pravafenix fenofibrate / pravastatin Laboratoires SMB S.A. Pravafenix is indicated for the treatment of high-coronary-heart-disease (CHD)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol (C)levels whose LDL-C levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.
Pregabalin Mylan pregabalin Generics (UK) Limited EpilepsyPregabalin Mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety DisorderPregabalin Mylan is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Pregabalin Mylan Pharma pregabalin Generics UK Limited Neuropathic pain Pregabalin Mylan Pharma is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Pregabalin Pfizer pregabalin Pfizer Limited Neuropathic painPregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults. EpilepsyPregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety DisorderPregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Pregabalin Sandoz pregabalin Sandoz GmbH Neuropathic pain Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.Epilepsy Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety Disorder Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Pregabalin Sandoz GmbH pregabalin Sandoz GmbH Epilepsy Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety Disorder Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Pregabalin Zentiva pregabalin Zentiva, k.s. EpilepsyPregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorderPregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1) Novartis Vaccines and Diagnostics S.r.l. Active immunisation against H5N1 subtype of Influenza A virus.This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain.Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic should be used in accordance with official recommendations.
Prepandrix A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) GlaxoSmithKline Biologicals S.A. Active immunisation against H5N1 subtype of influenza-A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Prepandrix should be used in accordance with official guidance.
Prevenar pneumococcal polysaccharide serotype 4 /pneumococcal polysaccharide serotype 6B /pneumococcal polysaccharide serotype 9V /pneumococcal polysaccharide serotype 14 / pneumococcal oligosaccharide serotype 18C /pneumococcal polysaccharide serotype 19F /pneumococcal polysaccharide serotype 23F Pfizer Limited Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children fromtwo months up tofive years of age. The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.
Prevenar 13 pneumococcal polysaccharide serotype 1 /pneumococcal polysaccharide serotype 14 /pneumococcal polysaccharide serotype 18C /pneumococcal polysaccharide serotype 19A / pneumococcal polysaccharide serotype 19F /pneumococcal polysaccharide serotype 23F /pneumococcal polysaccharide serotype 3 /pneumococcal polysaccharide serotype 4 / pneumococcal polysaccharide serotype 5 / pneumococcal polysaccharide serotype 6A / pneumococcal polysaccharide serotype 6B /pneumococcal polysaccharide serotype 7F /pneumococcal polysaccharide serotype 9V protein Pfizer Limited Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults 18 years of age and the elderly.See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Prezista darunavir Janssen-Cilag International NV Prezista film-coated tablets co-administered with low-dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human-immunodeficiency-virus (HIV-1) infection. Prezista75/150/300/600 mg tablets may be used to provide suitable dose regimens: for the treatment of HIV-1 infection in antiretroviral-treatment (ART)-experienced adult patients, including those that have been highly pretreated; for the treatment of HIV1 infection in paediatric patients from the age ofthreeyears and at least 15kg body weight. Prezista 400/800 mg tablets coadministered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV1) infection in adult patients. Prezista 400/800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV1 infection in adult and paediatric patients from the age of 12years and at least 40kg body weight who are: antiretroviral therapy (ART)nave; ARTexperienced with no darunavir resistance associated mutations (DRVRAMs) and who have plasma HIV1 RNA 100,000copies/ml and CD4+ cell count 100cellsx106/l. In deciding to initiate treatment with PREZISTA in such ARTexperienced patients, genotypic testing should guide the use of PREZISTA. Prezista 100-mg/ml oral suspension coadministered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV1) infection in adult and paediatric patients from the age of 3years and at least 15kg body weight. Prezista 100-mg/ml oral suspension coadministered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV1) infection in adult patients. In deciding to initiate treatment with Prezista coadministered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Prezista.
Prialt ziconotide Eisai Ltd. Ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.
Pritor telmisartan Bayer Pharma AG Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.
PritorPlus telmisartan / hydrochlorothiazide Bayer Pharma AG Treatment of essential hypertension. PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Privigen human normal immunoglobulin (IVIg) CSL Behring GmbH Replacement therapy in adults, and children and adolescents (0-18years) in: primary immunodeficiency (PID) syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, and children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain-Barr syndrome; Kawasaki disease; chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
Procoralan ivabradine hydrochloride Les Laboratoires Servier Treatment of coronary-artery disease Symptomatic treatment of chronic stable angina pectoris in coronary-artery-disease patients with normal sinus rhythm. Ivabradine is indicated: - in patients unable to tolerate or with a contra-indication to the use of beta-blockers; -or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is 60 beats per minute (bpm). Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure New York Heart Association II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Procysbi mercaptamine bitartrate Raptor Pharmaceuticals Europe BV Procysbi is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Prolia denosumab Amgen Europe B.V. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Prometax rivastigmine Novartis Europharm Limited Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
ProQuad virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella Sanofi Pasteur MSD, SNC ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age. ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.
Protaphane insulin human Novo Nordisk A/S Treatment of diabetes mellitus.
Protelos strontium ranelate Les Laboratoires Servier Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures. Treatment of severe osteoporosis in adult men at increased risk of fracture. The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.
Protopic tacrolimus Astellas Pharma Europe B.V. Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Children (two years of age and above) Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurringfour or more times per year) who have had an initial response to a maximum ofsix weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Puregon follitropin beta Merck Sharp & Dohme Limited In the female:Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Pylobactell 13C-urea Torbet Laboratories Limited This medicinal product is for diagnostic use only. For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.
Quadramet samarium [153Sm] lexidronam pentasodium CIS bio international Quadramet is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan. The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be confirmed prior to therapy.
Quinsair levofloxacin Aptalis Pharma SAS Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF, see section 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Qutenza capsaicin Astellas Pharma Europe B.V. Qutenza is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.
Raloxifene Teva raloxifene hydrochloride Teva B.V. Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.
Ranexa (previously Latixa) ranolazine Menarini International Operations Luxembourg S.A. (MIOL) Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).
Rapamune sirolimus Pfizer Limited Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids fortwo tothree months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued.
Rapilysin reteplase Actavis Group PTC ehf Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarctionwith persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction symptoms.
Rapiscan regadenoson Rapidscan Pharma Solutions EU Ltd   This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.
Raplixa human fibrinogen / human thrombin ProFibrix BV Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. Raplixa must be used in combination with an approved gelatin sponge. Raplixa is indicated in adults over 18 years of age.
Rasagiline ratiopharm rasagiline Teva B.V. Rasagiline ratiopharm is indicated for the treatment of idiopathic Parkinsons disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Rasilamlo aliskiren / amlodipine Novartis Europharm Ltd Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
Rasilez aliskiren Novartis Europharm Limited Treatment of essential hypertension.
Rasilez HCT aliskiren / hydrochlorothiazide Novartis Europharm Limited Treatment of essential hypertension in adults. Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Ratiograstim filgrastim Ratiopharm GmbH Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Ratiograstim is indicated for the treatment of persistent neutropenia (ANC 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Rebetol ribavirin Merck Sharp & Dohme Ltd   Tritherapy: Rebetol in combination with boceprevir and peginterferon alfa-2b is indicated for the treatment of chronic hepatitis-C (CHC)-genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to peginterferon alfa -2b and boceprevir summaries of product characteristics (SmPCs) when using Rebetol in combination with these medicines. Bitherapy: Rebetol is indicated for the treatment of chronic hepatitis-C-virus infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Rebetol monotherapy must not be used. Please refer to interferon alfa-2b and peginterferon alfa-2b SmPCs when using Rebetol in combination with these medicines. There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e. not alfa-2b). Previously untreated (nave) patients Adult patients (18 years of age or older) Rebetol is indicated for: tritherapy - in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients with chronic hepatitis-C-genotype-1 infection with compensated liver disease; bitherapy - in combination with interferon alfa-2b or peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis-C viral ribonucleic acid (HCV-RNA); bitherapy for the treatment of CHC infection in combination with peginterferon alfa-2b for patients with compensated cirrhosis and / or clinically stable HIV co-infection (see section 4.4). Bitherapy Paediatric patients (children three years of age and older and adolescents) Rebetol is indicated, in a combination regimen with peginterferon alfa-2b or interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case by case basis. Previously treated patients Adult patients: Rebetol is indicated for: tritherapy - in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients having CHC-genotype-1 infection with compensated liver disease; bitherapy - in combination with peginterferon alfa-2b, for the treatment of patients with chronic hepatitis C who have failed previous treatment with interferon alpha (pegylated or nonpegylated) alone or in combination with ribavirin (see section 5.1); bitherapy - in combination with interferon alfa-2b, for the treatment of patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed.
Rebif interferon beta-1a Merck Serono Europe Ltd Rebif is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing multiple sclerosis. Inclinical trials, this was characterised by twoor more acute exacerbations in theprevious two years. Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.
ReFacto AF moroctocog alfa Pfizer Ltd Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). ReFacto AF is appropriate for use in adults and children of all ages, including newborns. ReFacto AF does not contain von-Willebrand factor, and hence is not indicated in von-Willebrand's disease.
Relistor methylnaltrexone bromide TMC Pharma Services Ltd.   Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Relvar Ellipta fluticasone furoate / vilanterol Glaxo Group Ltd Asthma Indication: Relvar Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and as needed inhaled short acting beta2-agonists. COPD Indication: Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.
Remicade infliximab Janssen Biologics B.V.   Rheumatoid arthritis Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1). Adult Crohn's disease Remicade is indicated for: treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies; treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn's disease Remicade is indicated for treatment of severe, active Crohn's disease, in children and adolescents agedsix to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Remicade has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Remicade is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Remicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients agedsix to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Remicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Remicade should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Remicade has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1). Psoriasis Remicade is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA) (see section 5.1).
Removab catumaxomab Neovii Biotech GmbH Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Remsima infliximab Celltrion Healthcare Hungary Kft. Rheumatoid arthritis Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to diseasemodifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by Xray, has been demonstrated. Adult Crohns disease Remsimais indicated for: treatment of moderately to severely active Crohns disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies; treatment of fistulising, active Crohns disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohns disease Remsimais indicated for treatment of severe, active Crohns disease in children and adolescents agedsix to 17years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Remsimais indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Remsimais indicated for treatment of severely active ulcerative colitis in children and adolescents agedsix to 17years, who have had an inadequate response to conventional therapy including corticosteroids and 6MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Remsimais indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Remsimais indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Remsima should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by Xray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis Remsimais indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).
Renagel sevelamer Genzyme Europe B.V. Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.
Renvela sevelamer carbonate Genzyme Europe B.V. Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1.78 mmol/l. Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.
Repaglinide Accord repaglinide Accord Healthcare Ltd Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide Krka repaglinide Krka, d.d., Novo mesto Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide Teva repaglinide Teva Pharma B.V. Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repatha evolocumab Amgen Europe B.V. Hypercholesterolaemia and mixed dyslipidaemiaRepatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemiaRepatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
Replagal agalsidase alfa Shire Human Genetic Therapies AB Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (-galactosidase-A deficiency).
Repso leflunomide Teva B.V. Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a disease-modifying antirheumatic drug (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Resolor prucalopride succinate Shire Pharmaceuticals Ireland Ltd Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Retacrit epoetin zeta Hospira UK Limited Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood-saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (four or more units of blood for females orfive or more units for males). Retacrit can be used to reduce exposure to allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml).
Revatio sildenafil Pfizer Limited Treatment of adult patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients agedone year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease. Revatio solution for injection is for the treatment of adult patients with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable. Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Revestive teduglutide NPS Pharma Holdings Limited Revestive is indicated for the treatment of adult patients with short-bowel syndrome. Patients should be stable following a period of intestinal adaptation after surgery.
Revinty Ellipta fluticasone furoate / vilanterol trifenatate Glaxo Group Ltd Asthma IndicationRevinty Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and as needed inhaled short acting beta2-agonists. COPD IndicationRevinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.
Revlimid lenalidomide Celgene Europe Ltd Multiple myelomaRevlimid is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant (see section 4.2). Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromesRevlimid is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
Revolade eltrombopag olamine Novartis Europharm Limited Revolade is indicated for adult chronic-immune (idiopathic)-thrombocytopenic-purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Revolade may be considered as second-line treatment for adult non-splenectomised patients where surgery is contraindicated. Revolade is indicated in adult patients with chronic hepatitisC virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.
Reyataz atazanavir sulphate Bristol-Myers Squibb Pharma EEIG Reyataz capsules, co-administered with low-dose ritonavir, are indicated for the treatment of HIV1-infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products. Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (4protease inhibitormutations). There are very limited data available from children aged 6 to less than 18 years. The choice of Reyataz in treatment-experienced adult and paediatric patients should be based on individual viral resistance testing and the patients treatment history.
Rezolsta darunavir / cobicistat Janssen-Cilag International N.V. Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older. Genotypic testing should guide the use of Rezolsta.
Ribavirin Mylan (previously Ribavirin Three Rivers) ribavirin Generics [UK] Ltd Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b). Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product. Nave patients Adult patients Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types ofchronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum hepatitis-C-virus (HCV) RNA. Children and adolescents Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescentsthree years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4). Previously treatment-failure patients Adult patients Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
Ribavirin Teva ribavirin Teva B.V. Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e. not alfa-2b). Nave patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA. Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Teva is indicated, in a combination regimen with interferon alfa2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis. Previous treatment failure patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
Ribavirin Teva Pharma B.V. ribavirin Teva B.V. Ribavirin Teva Pharma B.V. is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three years of age or older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used.There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b). Nave patients Adult patients Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for HCV ribonucleic acid (HCV-RNA).Paediatric patients (childrenthree years of age and older and adolescents) Ribavirin Teva Pharma B.V. is indicated in a combination regimen with interferon alfa-2b, for the treatment of children and adolescentsthree years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition, that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis.Previous-treatment-failure patients Adult patients Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
Rilutek riluzole Aventis Pharma S.A. Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Rilutek extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Rilutek has not been shown to be effective in the late stages of ALS. Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.
Riluzole Zentiva riluzole Aventis Pharma S.A. Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1). Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS. Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.
Ristaben sitagliptin Merck Sharp & Dohme Ltd For adult patients with type-2 diabetes mellitus, Ristaben is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated-receptor-gamma (PPAR) agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Ristempa pegfilgrastim Amgen Europe B.V. Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)
Ristfor sitagliptin / metformin hydrochloride Merck Sharp & Dohme Ltd For patients with type-2 diabetes mellitus: Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPAR) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Ristfor is also indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Rivastigmine 1 A Pharma rivastigmine 1 A Pharma GmbH Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Rivastigmine Actavis rivastigmine hydrogen tartrate Actavis Group PTC ehf Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Rivastigmine Hexal rivastigmine Hexal AG   Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Rivastigmine Sandoz rivastigmine Sandoz GmbH Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Rixubis nonacog gamma Baxalta Innovations GmbH Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
RoActemra tocilizumab Roche Registration Limited RoActemra, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Rotarix human rotavirus, live attenuated GlaxoSmithKline Biologicals S.A. Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection. The use of Rotarix should be based on official recommendation.
RotaTeq rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1 Sanofi Pasteur MSD, SNC RotaTeq is indicated for the active immunisation of infants from the age ofsix weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection. RotaTeq is to be used on the basis of official recommendations.
Ruconest conestat alfa Pharming Group N.V. Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1-esterase-inhibitor deficiency.
Ryzodeg insulin degludec / insulin aspart Novo Nordisk A/S Treatment of diabetes mellitus in adults
Sabervel irbesartan Pharmathen S.A. Sabervel is indicated in adults for the treatment of essential hypertension.It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).
Samsca tolvaptan Otsuka Pharmaceutical Europe Ltd. Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).
Sancuso granisetron ProStrakan Ltd Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up tofive consecutive days. Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.
Savene dexrazoxane hydrochloride Clinigen Healthcare Ltd Savene is indicated for the treatment of anthracycline extravasation.
Saxenda liraglutide Novo Nordisk A/S Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of 30 kg/m (obese), or 27 kg/m to 30 kg/m (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.
Scenesse afamelanotide Clinuvel UK Limited Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Scintimun besilesomab CIS bio international   This medicinal product is for diagnostic use only and the approved indication is scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Scintimun should not be used for the diagnosis of diabetic foot infection.
Sebivo telbivudine Novartis Europharm Limited Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
Seebri Breezhaler glycopyrronium bromide Novartis Europharm Ltd Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Selincro nalmefene hydrochloride dihydrate H. Lundbeck A/S Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.
Senshio ospemifene Shionogi Limited Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
Sevelamer carbonate Zentiva sevelamer carbonate Genzyme Europe BV Sevelamer carbonate Zentiva is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Zentiva is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1.78 mmol/L. Sevelamer carbonate Zentiva should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Sifrol pramipexole dihydrochloride monohydrate Boehringer Ingelheim International GmbH Sifrolis indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa)or in combination with levodopa,i.e. over the course of the disease, though to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Sifrolis indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).
Signifor pasireotide Novartis Europharm Limited Signifor is indicated for the treatment of adult patients with Cushings disease for whom surgery is not an option or for whom surgery has failed. Signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Siklos hydroxycarbamide Addmedica Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome (see section 5.1).
Silapo epoetin zeta Stada Arzneimittel AG Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated withCRF in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (see section 4.4); Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (see section 4.4); treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, preexisting anaemia at the start of chemotherapy). Silapo can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Sildenafil Actavis sildenafil Actavis Group PTC ehf Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Actavis to be effective, sexual stimulation is required.
Sildenafil ratiopharm sildenafil Ratiopharm GmbH Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for sildenafil to be effective, sexual stimulation is required.
Sildenafil Teva sildenafil Teva B.V.   Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Teva to be effective, sexual stimulation is required.
Silgard human papillomavirus type 11 L1 protein /human papillomavirus type 16 L1 protein /human papillomavirus type 18 L1 protein/human papillomavirus type 6 L1 protein Merck Sharp & Dohme Ltd Silgard is a vaccine for use from the age of 9years for the prevention of: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acuminata) causally related to specific HPV types. See sections4.4 and 5.1 for important information on the data that support this indication. The use of Silgard should be in accordance with official recommendations.
Silodyx silodosin Recordati Ireland Ltd Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
Simbrinza brinzolamide / brimonidine tartrate Alcon Laboratories (UK) Ltd Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.
Simponi golimumab Janssen Biologics B.V. Arthritis, rheumatoid Axial spondyloarthritis: - Spondylitis, ankylosing - Nonradiographic axial spondyloarthritis (nrAxial SpA) Arthritis, psoriatic Colitis, ulcerative
Simulect basiliximab Novartis Europharm Limited Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Sirturo bedaquiline fumarate Janssen-Cilag International N.V. Indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Sivextro tedizolid phosphate CUBIST (UK) LTD Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
Soliris eculizumab Alexion Europe SAS Soliris is indicated in adults and children for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).
Somac Control pantoprazole Takeda GmbH Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Somatropin Biopartners somatropin BioPartners GmbH Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD). Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD. Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations ( -2 standard-deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.
Somavert pegvisomant Pfizer Limited Treatment of adultpatients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerate.
Sonata zaleplon Meda AB Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
SonoVue sulphur hexafluoride Bracco International B.V. This medicinal product is for diagnostic use only. SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, which results in an improved signal-to-noise ratio. SonoVue should only be used in patients where study without contrast enhancement is inconclusive. Echocardiography SonoVue is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left-ventricular endocardial border delineation.
Sovaldi sofosbuvir Gilead Sciences International Ltd Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
Spedra avanafil Menarini International Operations Luxembourg S.A. Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.
Sprycel dasatinib Bristol-Myers Squibb Pharma EEIG Sprycel is indicated for the treatment of adult patients with: newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase; chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate; Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Stalevo levodopa / carbidopa / entacapone Orion Corporation Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
Starlix nateglinide Novartis Europharm Ltd Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Stayveer bosentan monohydrate Marklas Nederlands BV    Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with World Health Organization (WHO)functional class III. Efficacy has been shown in: primary (idiopathic and familial) PAH; PAH secondary to scleroderma without significant interstitial pulmonary disease; PAH associated with congenital systemic-to-pulmonary shunts and Eisenmengers physiology. Some improvements have also been shown in patients with PAH WHO functional class II. Stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.
Stelara ustekinumab Janssen-Cilag International NV Plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen ultraviolet A. Paediatric plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis Stelara, alone or in combination withmethotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.
Stivarga regorafenib Bayer Pharma AG Stivarga is indicated for the treatment of adult patients with: metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy. unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
Stocrin efavirenz Merck Sharp & Dohme Ltd. Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and childrenthree years of age and older. Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.
Stribild elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil fumarate Gilead Sciences International Limited Treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years and over who are antiretroviral treatment-nave or are infected with HIV 1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.
Suboxone buprenorphine / naloxone RB Pharmaceuticals Ltd. Substitution treatment for opioid-drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Sustiva efavirenz Bristol-Myers Squibb Pharma EEIG Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and childrenthree years of age and older. Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.
Sutent sunitinib Pfizer Limited Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and / or metastatic malignant GIST after failure of imatinib-mesilate treatment due to resistance or intolerance. Metastatic renal-cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced / MRCC in adults. Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well differentiated pNET with disease progression in adults. Experience with Sutent as first-line treatment is limited.
Sycrest asenapine maleate N.V. Organon Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
Sylvant siltuximab Janssen-Cilag International NV Sylvant is indicated for the treatment of adult patients with multicentric Castlemans disease (MCD who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Synagis palivizumab AbbVie Ltd   Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: children born at 35 weeks of gestation or less and less thansix months of age at the onset of the RSV season; children less thantwo years of age and requiring treatment for bronchopulmonary dysplasiawithin the lastsix months; children less thantwo years of age and with haemodynamically significant congenital heart disease.
Synflorix pneumococcal polysaccharide serotype 1 /pneumococcal polysaccharide serotype 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, 23f /pneumococcal polysaccharide serotype 14 /pneumococcal polysaccharide serotype 18c /pneumococcal polysaccharide serotype 19f / pneumococcal polysaccharide serotype 23f /pneumococcal polysaccharide serotype 4 /pneumococcal polysaccharide serotype 5 /pneumococcal polysaccharide serotype 6b /pneumococcal polysaccharide serotype 7f /pneumococcal polysaccharide serotype 9v GlaxoSmithKline Biologicals S.A. Active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children fromsix weeks up tofive years of age. See sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes. The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.
Synjardy empagliflozin / metformin Boehringer Ingelheim GmbH Synjardy is indicated in adults aged 18years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients inadequately controlled on their maximally tolerated dose of metformin alone; in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin (see sections 4.5 and 5.1 for available data on different combinations); in patients already being treated with the combination of empagliflozin and metformin as separate tablets.
TachoSil human fibrinogen / human thrombin Takeda Austria GmbH TachoSil is indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient.
Tadalafil Mylan tadalafil Generics (UK) Limited Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women.
Tafinlar dabrafenib Novartis Europharm Limited Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Tamiflu oseltamivir Roche Registration Ltd. Treatment of influenza Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.Prevention of influenza Post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Tamiflu for prevention of influenza should be determined on a case-by-case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Tamiflu is indicated for post-exposure prevention of influenza in infantsless than 1 yearof age during a pandemic-influenza outbreak. Tamiflu is not a substitute for influenza vaccination. The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.
Tandemact pioglitazone / glimepiride Takeda Pharma A/S Tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Tarceva erlotinib Roche Registration Limited Non-small-cell lung cancer (NSCLC) Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR-activating mutations. Tarceva is also indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic NSCLC with stable disease afterfour cycles of standard platinum-based first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with epidermal-growth-factor-receptor (EGFR) IHC-negative tumours (see section 5.1). Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1). No survival advantage could be shown for patients with locally advanced disease.
Targretin bexarotene Eisai Ltd Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.
Tasermity sevelamer hydrochloride Genzyme Europe BV Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Tasigna nilotinib Novartis Europharm Ltd 150 mg Tasigna is indicated for the treatment of adult patients with newly diagnosed Philadelphia-chromosome-positive chronic myelogenous leukaemia (CML) in the chronic phase. 200 mg Tasigna is indicated for the treatment of adult patients with: newly diagnosed Philadelphia-chromosome-positive CML in the chronic phase; chronic phase and accelerated phase Philadelphia-chromosome-positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available.
Tasmar tolcapone Meda AB Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinsons disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors. Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa. Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.
Taxotere docetaxel Aventis Pharma S.A. Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancerTaxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancerTaxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinomaTaxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancerTaxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Tecfidera dimethyl fumarate Biogen Idec Ltd Treatment of adult patients with relapsing remitting multiple sclerosis.
Telmisartan Actavis telmisartan Actavis Group PTC ehf Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type 2 diabetes mellitus with documented target organ damage.
Telmisartan Teva telmisartan Teva B.V. Treatment of essential hypertension in adults
Telmisartan Teva Pharma telmisartan Teva B.V. Treatment of essential hypertension in adults
Telzir fosamprenavir calcium ViiV Healthcare UK Limited   Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children ofsix years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents. In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied. In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.
Temodal temozolomide Merck Sharp & Dohme Ltd. Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Temomedac temozolomide medac Gesellschaft für klinische Spezialpräparate mbH Temomedac hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Temozolomide Accord temozolomide Hospira UK Ltd For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Temozolomide Hexal temozolomide Hexal AG For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Temozolomide Sandoz temozolomide Sandoz Pharmaceutical GmbH For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Temozolomide Sun temozolomide Sun Pharmaceutical Industries Europe B.V. Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Temozolomide Teva temozolomide Teva Pharma B.V.   For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Tepadina thiotepa ADIENNE S.r.l. In combination with other chemotherapy medicinal products: 1) with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; 2) when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.". It is proposed that Tepadina must be prescribed by physicians experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Tesavel sitagliptin Merck Sharp & Dohme Ltd For patients with type-2 diabetes mellitus, Tesavel is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a PPAR agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control; a peroxisome-proliferator-activated-receptor-gamma(PPAR) agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Tesavel is also indicated as add on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.
Tevagrastim filgrastim Teva GmbH Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Teysuno tegafur / gimeracil / oteracil Nordic Group BV Teysuno is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin.
Thalidomide Celgene (previously Thalidomide Pharmion) thalidomide Celgene Europe Limited   Thalidomide Celgene in combination with melphalan and prednisone as first-line treatment of patients with untreated multiple myeloma, aged 65 years or ineligible for high-dose chemotherapy. Thalidomide Celgene is prescribed and dispensed according to the ThalidomideCelgene Pregnancy Prevention Programme.
Thymanax agomelatine Servier (Ireland) Industries Ltd Treatment of major depressive episodes in adults.
Thyrogen thyrotropin alfa Genzyme Europe B.V. Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone-suppression therapy (THST). Low-risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and norecombinant human (rh) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels. Thyrogen is indicated for pre-therapeutic stimulation in combination with 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.
Tivicay dolutegravir ViiV Healthcare Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age.
Tobi Podhaler tobramycin Novartis Europharm Ltd.   Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Tolucombi telmisartan / hydrochlorothiazide Krka, d.d., Novo mesto Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Tolura telmisartan Krka, d.d., Novo mesto   Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or; type 2 diabetes mellitus with documented target organ damage.
Topotecan Actavis topotecan Actavis Group PTC ehf Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.
Topotecan Hospira topotecan Hospira UK Ltd   Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.
Topotecan Teva topotecan Teva B.V. Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy; patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Torisel temsirolimus Pfizer Limited Renal-cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors. Mantle-cell lymphoma Torisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).
Toujeo (previously Optisulin) insulin glargine sanofi-aventis Deutschland GmbH Treatment of diabetes mellitus in adults, adolescents and children agedtwoyears and above
Tovanor Breezhaler glycopyrronium bromide Novartis Europharm Ltd. Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Toviaz fesoterodine fumarate Pfizer Limited Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.
Tracleer bosentan monohydrate Actelion Registration Ltd Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in: Primary (idiopathic and familial) PAH PAH secondary to scleroderma without significant interstitial pulmonary disease PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology Some improvements have also been shown in patients with PAH WHO functional class II. Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Tractocile atosiban acetate Ferring Pharmaceuticals A/S Tractotile is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30seconds duration at a rate of4 per 30minutes; a cervical dilation of 1 to 3cm (0-3 for nulliparas) and effacement of50%; a gestational age from 24 until 33 completed weeks; a normal foetal heart rate.
Trajenta linagliptin Boehringer Ingelheim International GmbH Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. as combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Translarna ataluren PTC Therapeutics International Limited Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 5 years and older.
Travatan travoprost Alcon Laboratories (UK) Ltd Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 2 months to 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).
Tresiba insulin degludec Novo Nordisk A/S Treatment of diabetes mellitus in adults.
Trisenox arsenic trioxide Teva B.V. Trisenox is indicated for induction of remission and consolidation in adult patients with relapsed / refractory acute promyelocytic leukaemia (APL), characterised by the presence of the t(15;17) translocation and / or the presence of the pro-myelocytic leukaemia / retinoic-acid-receptor alpha (PML/RAR-alpha) gene. Previous treatment should have included a retinoid and chemotherapy. The response rate of other acute myelogenous leukaemia subtypes to Trisenox has not been examined.
Triumeq abacavir sulfate / dolutegravir sodium / lamivudine ViiV Healthcare UK Limited Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg. Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Trizivir abacavir (as sulfate) / lamivudine / zidovudine ViiV Healthcare UK Limited   Trizivir is indicated for the treatment of human-immunodeficiency-virus (HIV) infection in adults. This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages. It is recommended that treatment is started with abacavir, lamivudine,and zidovudine separately for the firstsix to eight weeks. The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues. The demonstration of the benefit of Trizivir is mainly based on results of studies performed in treatment naive patients or moderately antiretroviral experienced patients with non-advanced disease. In patients with high viral load (100,000 copies/ml) choice of therapy needs special consideration. Overall, the virologic suppression with this triple nucleoside regimen could be inferior to that obtained with other multitherapies notably including boosted protease inhibitors or non-nucleoside reverse-transcriptase inhibitors, therefore the use of Trizivir should only be considered under special circumstances (e.g. co-infection with tuberculosis). Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir (see 'management after an interruption of Trizivir therapy'). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.
Trobalt retigabine Glaxo Group Limited   Trobalt is indicated as adjunctive treatment of drug-resistant partial-onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated.
Trulicity dulaglutide Eli Lilly Nederland B.V. Trulicity is indicated in adults with type-2 diabetes mellitus to improve glycaemic control as: MonotherapyWhen diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. Add-on therapyIn combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Truvada emtricitabine / tenofovir disoproxil fumarate Gilead Sciences International Limited Truvada is a fixed dose combination of emtricitabine and tenofovir disoproxil fumarate. It is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. The demonstration of the benefit of the combination emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy is based solely on studies performed in treatment-naive patients.
Twinrix Adult hepatitisA virus (inactivated) / hepatitis B surface antigen GlaxoSmithKline Biologicals S.A. Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Twinrix Paediatric hepatitis-A virus(inactivated) / hepatitis-B surface antigen GlaxoSmithKline Biologicals S.A. Twinrix Paediatric is indicated for use in non-immune infants, children and adolescents fromone year up to and including 15 years who are at risk of both hepatitis-A and hepatitis-B infection.
Twynsta telmisartan / amlodipine Boehringer Ingelheim International GmbH Treatment of essential hypertension in adults: Add-on therapy Twynsta is indicated in adults whose blood pressure is not adequately controlled on amlodipine. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.
Tybost cobicistat on silicon dioxide Gilead Sciences International Ltd Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human-immunodeficiency-virus-1 (HIV-1)-infected adults.
Tygacil tigecycline Pfizer Ltd. Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4) Complicated intra-abdominal infections (cIAI) Tygacil should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.
Tysabri natalizumab Biogen Idec Limited Tysabri is indicated as single disease-modifying therapy in highly active relapsing-remitting multiple sclerosis for the following patient groups: patients with high disease activity despite treatment with a beta-interferon.These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of a beta-interferon. Patients should have had at leastone relapse in the previous year while on therapy, and have at leastnine T2 hyperintense lesions in cranial magnetic resonance imaging (MRI) or at leastone gadolinium-enhancing lesion. A 'non-responder' could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year; or: patients with rapidly evolving severe relapsing-remitting multiple sclerosis defined bytwo or more disabling relapses in one year, and withone or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Tyverb lapatinib Novartis Europharm Limited Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
Ultibro Breezhaler indacaterol / glycopyrronium bromide Novartis Europharm Ltd Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Ulunar Breezhaler glycopyrronium bromide / indacaterol maleate Novartis Europharm Ltd Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Urorec silodosin Recordati Ireland Ltd Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Valdoxan agomelatine Les Laboratoires Servier Treatment of major depressive episodes in adults.
Vaniqa eflornithine Almirall, S.A. Treatment of facial hirsutism in women.
Vantavo (previously Alendronate sodium and colecalciferol, MSD) alendronic acid / colecalciferol Merck Sharp & Dohme Ltd Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency. Vantavo reduces the risk of vertebral and hip fractures. Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin-D supplementation and are at risk of vitamin-D insufficiency. Vantavo reduces the risk of vertebral and hip fractures.
Vantobra tobramycin Pari Pharma GmbH Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Vargatef nintedanib Boehringer Ingelheim International GmbH Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.
Vectibix panitumumab Amgen Europe B.V. Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in combination with FOLFOX or FOLFIRI. in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Vedrop tocofersolan Orphan Europe S.A.R.L. Vedrop is indicated in vitamin-E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.
Velcade bortezomib Janssen-Cilag International NV Velcade as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.Velcade in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation.Velcade in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Velmetia sitagliptin / metformin hydrochloride Merck Sharp & Dohme Ltd For patients with type-2 diabetes mellitus: Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Velmetia is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Velmetia is indicated as triple combination therapy with a PPAR agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist. Velmetia is also indicated as add on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.
Velphoro mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches Vifor Fresenius Medical Care Renal Pharma France Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease.
Ventavis iloprost Bayer Schering Pharma AG Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.
Vepacel Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1) Baxalta Innovations GmbH    Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Vepacelshould be used in accordance with Official guidance.
Vfend voriconazole Pfizer Limited Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of in candidaemia non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Vfend should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Viagra sildenafil Pfizer Limited Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Viagra to be effective, sexual stimulation is required.
Vibativ telavancin Clinigen Healthcare Ltd Vibativ is indicated for the treatment of adults with nosocomial pneumoniaincluding ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA).Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Victoza liraglutide Novo Nordisk A/S Victoza is indicated for treatment of adults with type-2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.
Victrelis boceprevir Merck Sharp & Dohme Ltd Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Vidaza azacitidine Celgene Europe Ltd. Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with: intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS); chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder; acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification.
Viekirax ombitasvir / paritaprevir / ritonavir AbbVie Ltd Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.For hepatitis C virus (HCV) genotype specific activity.
Vimizim recombinant human n-acetylgalactosamine-6-sulfatase (rhgalns) BioMarin Europe Ltd Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
Vimpat lacosamide UCB Pharma SA Vimpat is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
Vipdomet alogliptin benzoate / metformin hydrochloride Takeda Pharma A/S Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin; in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone; in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Vipidia alogliptin Takeda Pharma A/S Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
ViraferonPeg peginterferon alfa-2b Merck Sharp & Dohme Ltd   Adults (tritherapy) ViraferonPeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when ViraferonPeg is to be used in combination with these medicines. Adults (bitherapy and monotherapy) ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. ViraferonPeg in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy. Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin. Please refer to the ribavirin SmPC when ViraferonPeg is to be used in combination with ribavirin. Paediatric population (bitherapy) ViraferonPeg is indicated in a combination regimen with ribavirin for the treatment of childrenthree years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis. Please refer to the ribavirin SmPC for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.
Viramune nevirapine Boehringer Ingelheim International GmbH Tablets and oral suspension Viramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age. Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing. 50- and 100-mg prolonged-release tablets Viramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adolescents and children three years and above and able to swallow tablets. Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing. 400-mg prolonged-release tablets Viramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents and children three years and above and able to swallow tablets. Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.
Viread tenofovir disoproxil fumarate Gilead Sciences International Limited Viread 123-mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected paediatric patients, with nucleoside-reverse-transcriptase-inhibitor (NRTI) resistance or toxicities precluding the use of first line agents, aged 6 to 12 years who weigh from 17 kg to less than 22 kg. The choice of Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and / or treatment history of patients. Viread 163-mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected paediatric patients, with NRTI resistance or toxicities precluding the use of first-line agents, aged 6 to 12 years who weigh from 22 kg to less than 28 kg. The choice of Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and / or treatment history of patients. Viread 204-mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to 12 years who weigh from 28 kg to less than 35 kg. The choice of Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and / or treatment history of patients. Viread 245-mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. In adults, the demonstration of the benefit of Viread in HIV-1 infection is based on results of one study in treatment-nave patients, including patients with a high viral load ( 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure ( 10,000 copies/ml, with the majority of patients having 5,000 copies/ml). Viread 245-mg film-coated tablets are also indicated for the treatment of HIV-1-infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to 18 years. The choice of Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and / or treatment history of patients. Viread 245-mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease, with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active inflammation and / or fibrosis; decompensated liver disease. Viread 245-mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to 18 years of age with: compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and / or fibrosis. Viread 33-mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to 6 years of age, and above 6 years of age for whom a solid dosage form is not.
Visudyne verteporfin Novartis Europharm Limited Visudyne is indicated for the treatment of: adultswith exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or; adultswith subfoveal choroidal neovascularisation secondary to pathological myopia.
Vitekta elvitegravir Gilead Sciences International Ltd Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.
Vivanza vardenafil Bayer Pharma AG   Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vivanza to be effective, sexual stimulation is required. Vivanza is not indicated for use by women.
Vizamyl flutemetamol (18F) GE Healthcare Ltd This medicinal product is for diagnostic use only.Vizamyl is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimers disease (AD) and other causes of cognitive impairment. Vizamyl should be used in conjunction with a clinical evaluation.A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.
Vizarsin sildenafil Krka, d.d., Novo mesto Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vizarsin to be effective, sexual stimulation is required.
Vokanamet canagliflozin / metformin hydrochloride Janssen-Cilag International N.V. Vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: - in patients not adequately controlled on their maximally tolerated doses of metformin alone - in patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control. - in patients already being treated with the combination of canagliflozin and metformin as separate tablets
Volibris ambrisentan Glaxo Group Ltd Volibris is indicated for the treatment of patients with pulmonary arterial hypertension (PAH) classified as World Health Organization functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective-tissue disease.
Voncento human coagulation factor VIII / von Willebrand factor CSL Behring GmbH Von Willebrand disease (VWD) Treatment of haemorrhage or prevention and treatment of surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Haemophilia A (congenital factor-VIII deficiency) Prophylaxis and treatment of bleeding in patients with haemophilia A.
Voriconazole Accord voriconazole Accord Healthcare Ltd.     Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children agedtwo years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.
Voriconazole Hospira voriconazole Hospira UK limited Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections.
Votrient pazopanib Novartis Europharm Limited   Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft-tissue sarcoma (STS) Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy. Efficacy and safety have only been established in certain STS histological tumour subtypes.
Votubia everolimus Novartis Europharm Ltd Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in diseaserelated symptoms, has not been demonstrated.
Vpriv velaglucerase alfa Shire Pharmaceuticals Ireland Ltd.   Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.
Vylaer Spiromax budesonide / formoterol fumarate dihydrate Teva Pharma B.V. Vylaer Spiromax is indicated in adults 18 years of age and older only. AsthmaVylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting 2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and as needed inhaled short-acting 2 adrenoceptor agonists.or in patients already adequately controlled on both inhaled corticosteroids and long-acting 2 adrenoceptor agonists. COPDSymptomatic treatment of patients with severe COPD (FEV1 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Vyndaqel tafamidis Pfizer Ltd Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Wilzin zinc Orphan Europe S.A.R.L. Treatment of Wilson's disease.
Xadago safinamide methanesulfonate Zambon SpA Xadago is indicated for the treatment of adult patients with idiopathic Parkinsons disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
Xagrid anagrelide Shire Pharmaceutical Contracts Limited Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. An at-risk patient An at-risk ET is defined by one or more of the following features: 60 years of age or; aplatelet count 1000 x 109/l or; ahistory of thrombohaemorrhagic events.
Xalkori crizotinib Pfizer Ltd Xalkori is indicated for the treatment of adults with previously treated anaplastic-lymphoma-kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC).
Xaluprine (previously Mercaptopurine Nova Laboratories) 6-mercaptopurine monohydrate Nova Laboratories Ltd Xaluprineis indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Xarelto rivaroxaban Bayer Pharma AG Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age - 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.
Xelevia sitagliptin Merck Sharp & Dohme Ltd For adult patients with type-2 diabetes mellitus, Xelevia is indicated to improve glycaemic control: as monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with: metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e. a thiazolidinedione) when use of aPPAR agonist is appropriate and when diet and exercise plus thePPAR agonist alone do not provide adequate glycaemic control; as triple oral therapy in combination with: a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; a PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Xeloda capecitabine Roche Registration Limited Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Xeloda is indicated for the treatment of metastatic colorectal cancer. Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Xeloda in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Xenical orlistat Roche Registration Ltd. Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI 28 kg/m2) with associated risk factors. Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.
Xeplion paliperidone palmitate Janssen-Cilag International N.V. Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Xeristar duloxetine Eli Lilly Nederland B.V. Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Xeristar is indicated in adults. For further information see section 5.1.
Xgeva denosumab Amgen Europe B.V. Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Xiapex collagenase Clostridium histolyticum Swedish Orphan Biovitrum AB Xiapex is indicated for the treatment of Dupuytrens contracture in adult patients with a palpable cord.
Xigduo metformin hydrochloride / dapagliflozin propanediol monohydrate Bristol-Myers Squibb/AstraZeneca EEIG Xigduo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients inadequately controlled on their maximally tolerated dose of metformin alone in combination with other glucose lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products/li in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.
Xiliarx vildagliptin Novartis Europharm Limited Vildagliptin is indicated in the treatment of type-2 diabetes mellitus in adults: as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance; a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate; as triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control; vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.
Xofigo radium Ra223 dichloride Bayer Pharma AG Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Xolair omalizumab Novartis Europharm Ltd Allergic asthma Xolair is indicated in adults, adolescents and children (6 to 12 years of age). Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2). Adults and adolescents (12 years of age and older) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to 12 years of age) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2). Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
Xoterna Breezhaler indacaterol / glycopyrronium bromide Novartis Europharm Ltd Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Xtandi enzalutamide Astellas Pharma Europe B.V. Treatment of adult men with metastatic castrationresistant prostate cancer whose disease has progressed on or after docetaxel therapy.
Xultophy insulin degludec / liraglutide Novo Nordisk A/S Xultophy is indicated for the treatment of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.
Xydalba dalbavancin hcl Durata Therapeutics International B.V. Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
Xyrem sodium oxybate UCB Pharma Ltd Treatment of narcolepsy with cataplexy in adult patients.
Yellox bromfenac sodium sesquihydrate Croma-Pharma GmbH Treatment of postoperative ocular inflammation following cataract extraction in adults.
Yentreve duloxetine Eli Lilly Nederland B.V. Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).
Yervoy ipilimumab Bristol-Myers Squibb Pharma EEIG Yervoy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Yondelis trabectedin Pharma Mar S.A. Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Ytracis yttrium [90Y] chloride CIS bio international To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.Radiopharmaceutical precursor - Not intended for direct application to patients.
Yttriga yttrium [90Y] chloride Eckert & Ziegler Radiopharma GmbH To be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.Radiopharmaceutical precursor - Not intended for direct use in patients.
Zalasta olanzapine Krka Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Zaltrap aflibercept Sanofi-Aventis Groupe Treatment of metastatic colorectal cancer (MCRC).
Zarzio filgrastim Sandoz GmbH Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPC). In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Zavesca miglustat Actelion Registration Ltd. Zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type-C disease.
Zebinix eslicarbazepine acetate BIAL - Portela & Ca, S.A. Zebinix is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
Zeffix lamivudine Glaxo Group Ltd Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1); decompensated liver disease in combination with a second agent without cross-resistance to lamivudine (see section 4.2).
Zelboraf vemurafenib Roche Registration Ltd Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.
Zerit stavudine Bristol-Myers Squibb Pharma EEIG Hard capsules Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age ofthree months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible. Powder for oral solution Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.
Zevalin ibritumomab tiuxetan Spectrum Pharmaceuticals B.V. Zevalin is indicated in adults. [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Ziagen abacavir ViiV Healthcare UK Limited Ziagen is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-nave adult patients on combination therapy. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir (see 'management after an interruption of Ziagen therapy'). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.
Zinforo ceftaroline fosamil AstraZeneca AB Zinforo is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): complicated skin and soft tissue infections (cSSTI); community-acquired pneumonia (CAP). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Zoely nomegestrol acetate / estradiol Teva B.V. Oral contraception
Zoledronic Acid Accord zoledronic acid monohydrate Accord Healthcare Limited Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Zoledronic acid Actavis zoledronic acid monohydrate Actavis Group PTC ehf   Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia.
Zoledronic Acid Hospira zoledronic acid monohydrate Hospira UK Ltd 4 mg / 5 ml and 4 mg / 100 ml: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 5 mg / 100 ml: Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Paget's disease of the bone in adults.
Zoledronic acid medac zoledronic acid monohydrate medac Gesellschaft für klinische Spezialpräparate mbH Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Zoledronic acid Mylan zoledronic acid Mylan S.A.S. Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Zoledronic acid Teva zoledronic acid Teva B.V. Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.
Zoledronic acid Teva Generics zoledronic acid monohydrate Teva Generics B.V Treatment of osteoporosis in post-menopausal women in adult men at increased risk of fracture, including those with recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women in adult men at increased risk of fracture. Treatment of Paget's disease of the bone in adults.
Zoledronic acid Teva Pharma zoledronic acid Teva B.V. Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Pagets disease of the bone in adults.
Zomarist vildagliptin / metformin hydrochloride Novartis Europharm Limited Zomarist is indicated in the treatment of type-2 diabetes mellitus: Zomarist is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. Zomarist is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea. Zomarist is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Zometa zoledronic acid / zoledronic acid monohydrate Novartis Europharm Limited Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Zonegran zonisamide Eisai Ltd Zonegran is indicated as: monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children agedsix years and above.
Zontivity vorapaxar sulfate Merck Sharp & Dohme Limited Zontivity, co-administered with acetylsalicylic acid (ASA) and, where appropriate, clopidogrel, is indicated for the reduction of atherothrombotic events in adult patients with a history of myocardial infarction (MI).
Zostavax varicella-zoster virus (live, attenuated) Sanofi Pasteur MSD, SNC Zostavax is indicated for prevention of herpes zoster ('zoster' or shingles) and herpes-zoster-related post-herpetic neuralgia. Zostavax is indicated for immunisation of individuals 50 years of age or older.
Zutectra human hepatitis-B immunoglobulin Biotest Pharma GmbH Prevention of hepatitis-B-virus (HBV) re-infection in HBV-DNA negative patients 6 months after liver transplantation for hepatitis-B-induced liver failure. Zutectra is indicated in adults only. The concomitant use of adequate virostatic agents should be considered, if appropriate, as standard of hepatitis-B re-infection prophylaxis.
Zyclara imiquimod Meda AB Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
Zydelig idelalisib Gilead Sciences International Ltd Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
Zykadia ceritinib Novartis Europharm Ltd Treatment of anaplastic lymphomakinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer
Zyllt clopidogrel hydrogen sulphate Krka, d.d., Novo mesto Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; patients suffering from acute coronary syndrome: non-ST-segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Zypadhera olanzapine pamoate Eli Lilly Nederland B.V. Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Zyprexa olanzapine Eli Lilly Nederland B.V. Coated tablets Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. Injection Adults Zyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.
Zyprexa Velotab olanzapine Eli Lilly Nederland B.V. Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
Zytiga abiraterone acetate Janssen-Cilag International N.V. Treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated. Treatment of metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxelbased chemotherapy regimen.
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