Unió Europea - anglès - 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.

Unió Europea - anglès - 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.

Unió Europea - anglès - 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.

Unió Europea - anglès - 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.

Unió Europea - anglès - 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.

Unió Europea - anglès - 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.

Unió Europea - anglès - EMA (European Medicines Agency)

ratiopharm gmbh - desloratadine - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistamines for systemic use, - desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician

Unió Europea - anglès - EMA (European Medicines Agency)

teva b.v - desloratadine - rhinitis, allergic, perennial; rhinitis, allergic, seasonal - antihistamines for systemic use, - desloratadine teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.

Unió Europea - anglès - EMA (European Medicines Agency)

actavis group ptc ehf - oseltamivir - influenza, human - antivirals for systemic use, neuraminidase inhibitors - 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.

Unió Europea - anglès - EMA (European Medicines Agency)

teva b.v. - efavirenz - hiv infections - antivirals for systemic use - 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.