İrlanda - İngilizce - 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.

İrlanda - İngilizce - 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.

Avrupa Birliği - İngilizce - 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.,

Malta - İngilizce - Medicines Authority

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

Malta - İngilizce - Medicines Authority

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

Malta - İngilizce - Medicines Authority

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

Malta - İngilizce - Medicines Authority

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

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

actavis group ptc ehf - levetiracetam - epilepsy - antiepileptics, - levetiracetam actavis group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.levetiracetam actavis group is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Avrupa Birliği - İngilizce - 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.

İrlanda - İngilizce - 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