Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

mylan - imatinib mesilate - film-coated tablet - 400 mg - imatinib mesilate 478 mg - imatinib

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)

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.

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - imatinib mesylate 119.5 mg eqv imatinib base - tablet, film coated - 100 mg - imatinib mesylate 119.5 mg eqv imatinib base 100 mg

Malta - English - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - imatinib - film-coated tablet - imatinib 100 mg - antineoplastic agents

Malta - English - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents