European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and 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.- adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or 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 treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).- the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe 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 (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.  

Malta - English - Medicines Authority

aspen healthcare malta limited the corner, level 0 triq santa margerita siggiewi,, malta - imatinib - hard capsule - imatinib 100 milligram(s) - antineoplastic agents

Malta - English - Medicines Authority

aspen healthcare malta limited the corner, level 0 triq santa margerita siggiewi,, malta - imatinib - hard capsule - imatinib 400 milligram(s) - antineoplastic agents

Malta - English - Medicines Authority

cherubino limited - imatinib mesilate - hard capsule - imatinib mesilate 100 milligram(s) - antineoplastic agents

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

cipla malaysia sdn bhd - imatinib mesylate -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

cipla limited, india - imatinib mesylate - capsules - 400 mg

Australia - English - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - sunitinib malate, quantity: 50.118 mg (equivalent: sunitinib, qty 37.5 mg) - capsule, hard - excipient ingredients: croscarmellose sodium; mannitol; gelatin; pregelatinised maize starch; titanium dioxide; magnesium stearate; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

Australia - English - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - sunitinib malate, quantity: 50.118 mg (equivalent: sunitinib, qty 37.5 mg) - capsule, hard - excipient ingredients: gelatin; iron oxide yellow; pregelatinised maize starch; magnesium stearate; titanium dioxide; croscarmellose sodium; mannitol; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

Australia - English - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - sunitinib malate, quantity: 16.706 mg (equivalent: sunitinib, qty 12.5 mg) - capsule, hard - excipient ingredients: croscarmellose sodium; mannitol; gelatin; titanium dioxide; iron oxide red; magnesium stearate; pregelatinised maize starch; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

Australia - English - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - sunitinib malate, quantity: 66.824 mg (equivalent: sunitinib, qty 50 mg) - capsule, hard - excipient ingredients: iron oxide black; gelatin; iron oxide red; mannitol; iron oxide yellow; pregelatinised maize starch; titanium dioxide; magnesium stearate; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)