Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva b.v. - zoledronic acid - fractures, bone; cancer - drugs for treatment of bone diseases - prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.

Ευρωπαϊκή Ένωση - Αγγλικά - 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.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva pharma b.v. - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: , in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. , 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.,

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva b.v. - pioglitazone hydrochloride - diabetes mellitus, type 2 - alimentary tract and metabolism - pioglitazone is indicated in the treatment of type 2 diabetes mellitus:as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intoleranceas 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 sulphonylureaas 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.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva gmbh - dimethyl fumarate - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressants - dimethyl fumarate teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Ισραήλ - Αγγλικά - Ministry of Health

teva israel ltd - caffeine; chlorpheniramine maleate; paracetamol; phenylephrine hydrochloride - caplets - paracetamol 300 mg; chlorpheniramine maleate 2 mg; phenylephrine hydrochloride 10 mg; caffeine 30 mg - phenylephrine, combinations - phenylephrine, combinations - symptomatic relief of common cold, congestion associated with sinusitis, allergic rhinitis accompanied by fever and pain.

Ισραήλ - Αγγλικά - Ministry of Health

teva israel ltd - caffeine anhydrous; chlorpheniramine maleate; paracetamol; phenylephrine hydrochloride - tablets - paracetamol 300 mg; chlorpheniramine maleate 2.0 mg; phenylephrine hydrochloride 10 mg; caffeine anhydrous 30 mg - phenylephrine, combinations - symptomatic relief of common cold, congestion associated with sinusitis, allergic rhinitis accompanied by fever and pain.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - imatinib teva b.v. 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 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 b.v. is indicated for: , the 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. there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Ευρωπαϊκή Ένωση - Αγγλικά - 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