Ireland - English - HPRA (Health Products Regulatory Authority)

generics (uk) limited - imatinib - film-coated tablet - 400 milligram(s)

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.

European Union - English - EMA (European Medicines Agency)

pierre fabre medicament - vinflunine - carcinoma, transitional cell; urologic neoplasms - antineoplastic agents - javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.

Canada - English - Health Canada

bristol-myers squibb canada - mitomycin - powder for solution - 0.5mg - mitomycin 0.5mg - antineoplastic agents

Canada - English - Health Canada

bristol-myers squibb canada - mitomycin - powder for solution - 20mg - mitomycin 20mg - antineoplastic agents

Canada - English - Health Canada

cheplapharm arzneimittel gmbh - etoposide - capsule - 50mg - etoposide 50mg - antineoplastic agents

Canada - English - Health Canada

teva canada limited - etoposide - liquid - 20mg - etoposide 20mg - antineoplastic agents

Canada - English - Health Canada

pharmascience inc - epirubicin hydrochloride - solution - 2mg - epirubicin hydrochloride 2mg - antineoplastic agents

Canada - English - Health Canada

pfizer canada ulc - epirubicin hydrochloride - powder for solution - 10mg - epirubicin hydrochloride 10mg - antineoplastic agents

Canada - English - Health Canada

pfizer canada ulc - epirubicin hydrochloride - powder for solution - 50mg - epirubicin hydrochloride 50mg - antineoplastic agents