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

bioorganics bv microweg 22, 6545cm nijmegen, netherlands - imatinib - film-coated tablet - imatinib 100 mg - antineoplastic agents

Malta - English - Medicines Authority

bioorganics bv microweg 22, 6545cm nijmegen, netherlands - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - imatinib mesilate 478mg equivalent to imatinib free base 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib free base 400 mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry beige 85f97378 - imatinib mylan is indicated for the: - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) - treatment of adult and paediatric patients with ph+ cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - imatinib mesilate 478mg equivalent to imatinib 400 mg - capsule - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib 400 mg excipient: colloidal silicon dioxide crospovidone gelatin iron oxide red   iron oxide yellow   lactose magnesium stearate purified water titanium dioxide   - - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). - treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. - treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. - treatment of adult patients with relapsed or refractory ph+all as monotherapy. - treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). - treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - imatinib mesilate 478mg equivalent to imatinib 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib 400 mg excipient: colloidal silicon dioxide crospovidone hyprolose hypromellose iron oxide red iron oxide yellow macrogol 8000 magnesium stearate - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

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