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.

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - imatinib mesylate - film-coated tablet - 400 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 - imatinib - film-coated tablet - imatinib - antineoplastic agents

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - imatinib - film-coated tablet - imatinib 200 mg - antineoplastic agents

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - imatinib - film-coated tablet - imatinib 300 mg - antineoplastic agents

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents

Malta - English - Medicines Authority

actavis group h.f. reykjavikurvegur 78, 220 hafnarfjörður, iceland - betahistine dihydrochloride - tablet - betahistine dihydrochloride 8 mg - other nervous system drugs

Malta - English - Medicines Authority

actavis group h.f. reykjavikurvegur 78, 220 hafnarfjörður, iceland - betahistine dihydrochloride - tablet - betahistine dihydrochloride 16 mg - other nervous system drugs

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 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.