Israel - English - Ministry of Health

taro international ltd, israel - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib taro is indicated for the• treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase, accelerated phase or blast crisis.• treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). • adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.• treatment of adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. • treatment of adult patients with relapsed or refractory ph+ all as monotherapy. • treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.• treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet-derived growth factor receptor) gene re-arrangements. • treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fish demonstration of chic2 allele deletion) and for patients with hes and/or cel who are fip1l1- pdgfrα fusion kinase negative. • treatment of adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.

Israel - English - Ministry of Health

taro international ltd, israel - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib taro is indicated for the• treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase, accelerated phase or blast crisis.• treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). • adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.• treatment of adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. • treatment of adult patients with relapsed or refractory ph+ all as monotherapy. • treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.• treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet-derived growth factor receptor) gene re-arrangements. • treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fish demonstration of chic2 allele deletion) and for patients with hes and/or cel who are fip1l1- pdgfrα fusion kinase negative. • treatment of adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.

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)

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 red; iron oxide black; titanium dioxide; gelatin; mannitol; croscarmellose sodium; magnesium stearate; iron oxide yellow; 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: 33.412 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: titanium dioxide; gelatin; iron oxide red; mannitol; croscarmellose sodium; magnesium stearate; pregelatinised maize starch; iron oxide black; iron oxide yellow; 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: 16.706 mg (equivalent: sunitinib, qty 12.5 mg) - capsule, hard - excipient ingredients: magnesium stearate; mannitol; titanium dioxide; croscarmellose sodium; gelatin; pregelatinised maize starch; iron oxide red; 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: 33.412 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: iron oxide yellow; mannitol; croscarmellose sodium; titanium dioxide; iron oxide red; gelatin; pregelatinised maize starch; magnesium stearate; iron oxide black; 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)