Európai Unió - angol - EMA (European Medicines Agency)

teva pharma b.v. - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - combinations - 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 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 interventionst segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy

Európai Unió - angol - EMA (European Medicines Agency)

teva pharma b.v. - rivastigmine - dementia; alzheimer disease; parkinson disease - anticholinesterases - 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.

Európai Unió - angol - EMA (European Medicines Agency)

teva b.v. - topotecan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - antineoplastic agents - 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. , 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.,

Európai Unió - angol - EMA (European Medicines Agency)

teva b.v. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drugs for treatment of bone diseases - 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.,

Európai Unió - angol - 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.

Európai Unió - angol - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva is indicated for the treatment ofadult 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-pdgfrα rearrangement.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.imatinib teva is indicated forthe 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 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 gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib 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. 

Európai Unió - angol - EMA (European Medicines Agency)

teva b.v.  - irbesartan, hydrochlorothiazide - hypertension - agents acting on the renin-angiotensin system - 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.

Európai Unió - angol - EMA (European Medicines Agency)

teva b.v. - telmisartan - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension in adults.

Európai Unió - angol - EMA (European Medicines Agency)

teva b.v.  - olanzapine - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine 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.

Európai Unió - angol - EMA (European Medicines Agency)

teva b.v.  - temozolomide - glioma; glioblastoma - antineoplastic agents - 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.