European Union - English - EMA (European Medicines Agency)

actavis group ptc ehf - sildenafil - erectile dysfunction - urologicals - 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 actavis to be effective, sexual stimulation is required.

European Union - English - 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - voriconazole - film coated tablet - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - it is indicated in adults and children aged 2 years and above as follows: - treatment of invasive aspergillosis. - treatment of candidemia in non-neutropenic patients. - treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). - treatment of serious fungal infections caused by scedosporium spp. and fusarium spp

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - voriconazole - film coated tablet - 50 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - it is indicated in adults and children aged 2 years and above as follows: - treatment of invasive aspergillosis. - treatment of candidemia in non-neutropenic patients. - treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). - treatment of serious fungal infections caused by scedosporium spp. and fusarium spp.

European Union - English - EMA (European Medicines Agency)

actavis group ptc ehf - desloratadine - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistamines for systemic use, - treatment of allergic rhinitis and urticaria.

European Union - English - 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).

European Union - English - EMA (European Medicines Agency)

actavis group ptc ehf - telmisartan - hypertension - agents acting on the renin-angiotensin system - hypertensiontreatment of essential hypertension in adults.cardiovascular preventionreduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.

European Union - English - 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 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.,

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - imatinib mesilate - film-coated tablet - 100 milligram(s) - other antineoplastic agents - antineoplastic agents, protein kinase inhibitor - imatinib actavis group 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.

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - escitalopram - film-coated tablet - escitalopram 5 mg - psychoanaleptics