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European Union - English - EMA (European Medicines Agency)

clopidogrel ratiopharm gmbh

archie samiel s.r.o. - clopidogrel - 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.

European Union - English - EMA (European Medicines Agency)

docetaxel teva

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.

European Union - English - EMA (European Medicines Agency)

glidipion (previously pioglitazone actavis group)

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.

European Union - English - EMA (European Medicines Agency)

topotecan actavis

actavis group ptc ehf - topotecan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastic agents - topotecan monotherapy is indicated for the treatment of 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.,