Avrupa Birliği - İngilizce - 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.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

teva b.v.  - docetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancerdocetaxel 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 cancerdocetaxel 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 cancerdocetaxel teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.gastric adenocarcinomadocetaxel 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 cancerdocetaxel 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.

Avrupa Birliği - İngilizce - 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.

Avrupa Birliği - İngilizce - 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.

Avrupa Birliği - İngilizce - 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.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

actavis group ptc ehf    - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - 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.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.

Avrupa Birliği - İngilizce - 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.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - 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.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

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

Avrupa Birliği - İngilizce - 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.