Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - imatinib - film-coated tablet - 400 milligram(s) - other antineoplastic agents - antineoplastic agents, protein kinase inhibitor - imatinib clonmel is indicated in:
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.

Ireland - English - HPRA (Health Products Regulatory Authority)

jazz pharmaceuticals france sas - cristanspase - powder for solution for injection - 10000  international unit(s) - other antineoplastic agents; asparaginase

Ireland - English - HPRA (Health Products Regulatory Authority)

bristol-myers squibb pharmaceuticals uc - hydroxycarbamide - capsule, hard - 500 milligram(s) - other antineoplastic agents; hydroxycarbamide

Ireland - English - HPRA (Health Products Regulatory Authority)

cheplapharm arzneimittel gmbh - hydroxycarbamide - capsule, hard - other antineoplastic agents; hydroxycarbamide

Israel - English - Ministry of Health

cts ltd - asparaginase - powder for solution for injection - asparaginase 10000 iu/vial - asparaginase - asparaginase - acute lymphoblastic leukemia, acute myeloblastic leukemia.

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - 20 milligram(s)/millilitre - other antineoplastic agents; miltefosine

Malta - English - Medicines Authority

nordmedica a/s - amsacrine - concentrate for solution for infusion - amsacrine 50 mg/ml - antineoplastic agents

European Union - English - EMA (European Medicines Agency)

theravia - hydroxycarbamide - anemia, sickle cell - antineoplastic agents - siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.

Canada - English - Health Canada

jazz pharmaceuticals france sas - asparaginase - powder for solution - 10000unit - asparaginase 10000unit - antineoplastic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

neon healthcare ltd - hydroxycarbamide - oral capsule - 500mg