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

teva pharma australia pty ltd - dasatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: hyprolose; lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; triacetin - dasatinib is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

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

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 116 mg (equivalent: dasatinib, qty 100 mg) - tablet, film coated - excipient ingredients: hydrogenated castor oil; lactose; silicon dioxide; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

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

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 23.2 mg (equivalent: dasatinib, qty 20 mg) - tablet, film coated - excipient ingredients: lactose; croscarmellose sodium; triacetin; hydrogenated castor oil; magnesium stearate; titanium dioxide; silicon dioxide; microcrystalline cellulose; hypromellose - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

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

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 81.2 mg (equivalent: dasatinib, qty 70 mg) - tablet, film coated - excipient ingredients: silicon dioxide; croscarmellose sodium; magnesium stearate; triacetin; titanium dioxide; microcrystalline cellulose; lactose; hydrogenated castor oil; hypromellose - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

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

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 58 mg (equivalent: dasatinib, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hydrogenated castor oil; magnesium stearate; hypromellose; titanium dioxide; lactose; triacetin; silicon dioxide - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

European Union - English - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - imatinib teva b.v. 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 or blast crisis., adult 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. , the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib teva b.v. is indicated for: , 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 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. there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.1).

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

merck sharp & dohme (malaysia) sdn bhd - alendronate sodium; vitamin d3 100,000 i.u./g, ph. eur. -

Israel - English - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib - glivec 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. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).glivec 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.* adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Israel - English - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib - glivec 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. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec 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 for 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. * adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.