European Union - English - EMA (European Medicines Agency)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - protein kinase inhibitors - imatinib medac 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;adult and paediatric 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-pdgfrα rearrangement;adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp.the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft für klinische spezialpräparate mbh - methotrexate - solution for injection in pre-filled syringe - 50 milligram(s)/millilitre - other immunosuppressants; methotrexate

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - dacarbazine citrate - pdr for soln inj/inf - 100 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - dacarbazine citrate - pdr for soln inj/inf - 100 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - levofolinic acid sodium hydroxide - solution for inj/inf - 50

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - gemcitabine - pdr for soln for infusion - 200 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - gemcitabine - pdr for soln for infusion - 1 grams

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - gemcitabine - pdr for soln for infusion - 1500 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - gemcitabine - pdr for soln for infusion - 1500 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - gemcitabine - pdr for soln for infusion - 1 grams