Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva b.v.  - sildenafil - erectile dysfunction - drugs used in erectile dysfunction - treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. in order for sildenafil teva to be effective, sexual stimulation is required.,

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

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

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

actavis group ptc ehf - topotecan - 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 (see section 5.1).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 (see section 5.1).

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)

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 monotherapyin 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 withmetformin, 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 withmetformin 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 (see section 4.4).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 (see section 4.4).

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva b.v. - raloxifene hydrochloride - osteoporosis, postmenopausal - sex hormones and modulators of the genital system, - raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. a significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.when determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

actavis group ptc ehf - reteplase - myocardial infarction - antithrombotic agents - rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (ami) symptoms.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

teva b.v. - rasagiline - parkinson disease - anti-parkinson drugs - rasagiline ratiopharm is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

ratiopharm gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.ratiograstim is indicated for the treatment of persistent neutropenia (anc ≤ 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.