European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - follitropin beta - infertility; hypogonadism - sex hormones and modulators of the genital system, - 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 citratecontrolled 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.

European Union - English - EMA (European Medicines Agency)

actavis group hf - telmisartan, hydrochlorothiazide - essential hypertension - agents acting on the renin-angiotensin system, angiotensin ii antagonists and diuretics - 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.

European Union - English - EMA (European Medicines Agency)

actavis group ptc ehf - pemetrexed diacid monohydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed 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.pemetrexed 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.pemetrexed 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.

European Union - English - EMA (European Medicines Agency)

teva b.v. - rasagiline - parkinson disease - anti-parkinson drugs - 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.

European Union - English - EMA (European Medicines Agency)

teva gmbh - epoetin theta - kidney failure, chronic; anemia; cancer - other antianemic preparations - 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.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastic agents - capecitabine teva is indicated for the adjuvant treatment of patients following surgery of stage iii (dukes’ stage c) colon cancer.capecitabine teva is indicated for the treatment of metastatic colorectal cancer.capecitabine teva is indicated for first‑line treatment of advanced gastric cancer in combination with a platinum‑based 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.

European Union - English - EMA (European Medicines Agency)

teva b.v. - reslizumab - asthma - other systemic drugs for obstructive airway diseases, - cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - clopidogrel (as hydrogen sulfate) - acute coronary syndrome; peripheral vascular diseases; myocardial infarction; stroke - antithrombotic agents - secondary 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.

European Union - English - EMA (European Medicines Agency)

teva b.v. - colistimethate sodium - cystic fibrosis - antibacterials for systemic use, - colobreathe is indicated for the management of chronic pulmonary infections due to pseudomonas aeruginosa in patients with cystic fibrosis (cf) aged six years and older.consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

actavis group ptc ehf - desloratadine - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistamines for systemic use, - treatment of allergic rhinitis and urticaria.