Malta - engelsk - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - hydrochlorothiazide, valsartan - film-coated tablet - hydrochlorothiazide 160 mg valsartan 25 mg - agents acting on the renin-angiotensin system

Irland - engelsk - HPRA (Health Products Regulatory Authority)

teva b.v. - rosuvastatin - film-coated tablet - 40 milligram(s) - hmg coa reductase inhibitors; rosuvastatin - hmg-coa reductase inhibitors - treatment of hypercholesterolaemia adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type iia including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type iib) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or if such treatments are not appropriate. prevention of cardiovascular events prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular even

Irland - engelsk - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - tamsulosin hydrochloride - capsules modified release - 400 microgram - tamsulosin

Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - EMA (European Medicines Agency)

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

Den europeiske union - engelsk - EMA (European Medicines Agency)

teva pharma b.v. - entacapone - parkinson disease - anti-parkinson drugs - 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.

Den europeiske union - engelsk - EMA (European Medicines Agency)

teva pharma b.v. - ibandronic acid - breast neoplasms; neoplasm metastasis; fractures, bone; osteoporosis, postmenopausal - drugs for treatment of bone diseases - 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. a reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Den europeiske union - engelsk - EMA (European Medicines Agency)

teva pharma b.v.  - lamivudine, zidovudine - hiv infections - antivirals for systemic use - lamivudine/zidovudine teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (hiv) infection.

Den europeiske union - engelsk - EMA (European Medicines Agency)

teva pharma b.v. - leflunomide - arthritis, rheumatoid - immunosuppressants - 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.