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

novartis pharmaceuticals australia pty ltd - nilotinib hydrochloride monohydrate, quantity: 220.6 mg (equivalent: nilotinib, qty 200 mg) - capsule, hard - excipient ingredients: magnesium stearate; crospovidone; titanium dioxide; iron oxide yellow; poloxamer; gelatin; lactose monohydrate; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; iron oxide red; ethanol absolute; potassium hydroxide; ammonia; industrial methylated spirit; iron oxide black; sulfuric acid; lecithin; xanthan gum; benzoic acid; sorbic acid; methylcellulose; polyethylene glycol; silica dimethicone silylate; dimeticone - tasigna is indicated for the:,? treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (cml) in chronic phase. ? treatment of adults with chronic phase and accelerated phase philadelphia chromosome positive chronic myeloid leukaemia (cml) resistant to or intolerant of prior therapy including imatinib.

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

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 66.825 mg (equivalent: sunitinib, qty mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide black; iron oxide yellow; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib 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)

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 50.119 mg (equivalent: sunitinib, qty mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - arx-sunitinib 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)

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 33.413 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; iron oxide red; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide yellow; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib 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)

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 16.706 mg (equivalent: sunitinib, qty 12.5 mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; iron oxide red; titanium dioxide; purified water; croscarmellose sodium; povidone; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib 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).

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.

European Union - English - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva is indicated for the treatment ofadult 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.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.imatinib teva is indicated forthe 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 treatment.the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.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 gist and dfsp and on recurrence-free survival in adjuvant gist. 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. 

United States - English - NLM (National Library of Medicine)

wockhardt usa llc. - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia (ph+ cml). adult patients with myelodysplastic/myeloproliferative diseases associated with pdgfr (platelet-derived growth factor receptor) gene re-arrangements as determined with an fda-approved test [see dosage and administration (2.6)] . adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation as determined with an fda-approved test [see dosage and administration (2.7)] or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fish demonstratio

Israel - English - Ministry of Health

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