Irska - engleski - HPRA (Health Products Regulatory Authority)

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

Irska - engleski - HPRA (Health Products Regulatory Authority)

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

Malta - engleski - Medicines Authority

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

Malta - engleski - Medicines Authority

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

Malta - engleski - Medicines Authority

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

Malta - engleski - Medicines Authority

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

Malta - engleski - Medicines Authority

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

Malta - engleski - Medicines Authority

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

Irska - engleski - HPRA (Health Products Regulatory Authority)

cipla (eu) limited - imatinib mesilate - capsules hard - 100 milligram - other cytostatics - antineoplastic agents; protein kinase inhibitor - it s 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 and paediatric 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

Irska - engleski - HPRA (Health Products Regulatory Authority)

cipla (eu) limited - imatinib mesilate - capsules hard - 400 milligram - other cytostatics - antineoplastic agents; protein kinase inhibitor - it 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 and paediatric 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