Israel - English - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. * adult patients with relapsed or refractory ph + all as monotherapy. * adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration for chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation. * adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Ireland - English - HPRA (Health Products Regulatory Authority)

kyowa kirin limited - mitomycin - powder for solution for injection - 10 milligram(s) - other cytotoxic antibiotics; mitomycin

Ireland - English - HPRA (Health Products Regulatory Authority)

kyowa kirin limited - mitomycin - powder for solution for injection - 40 milligram(s) - other cytotoxic antibiotics; mitomycin

Ireland - English - HPRA (Health Products Regulatory Authority)

kyowa hakko kirin uk ltd - mitomycin - pdr for soln for injection - 2 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

kyowa hakko kirin uk ltd - mitomycin - pdr for soln for injection - 20 milligram

Malta - English - Medicines Authority

kohne pharma gmbh - imatinib 100 mg - film-coated tablet

Malta - English - Medicines Authority

kohne pharma gmbh - imatinib 400 mg - film-coated tablet

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - imatinib - film-coated tablet - imatinib 100 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents

Malta - English - Medicines Authority

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