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.

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - imatinib - film-coated tablet - 100 milligram(s) - other antineoplastic agents - protein-tyrosine kinase inhibitor - imatinib 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 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-pdgfr
rearrangement.

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - imatinib - film-coated tablet - 400 milligram(s) - other antineoplastic agents - protein-tyrosine kinase inhibitor - imatinib 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 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-pdgfr
rearrangement. adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) an

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

teva pharma australia pty ltd - dasatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; hyprolose; 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)

teva pharma australia pty ltd - dasatinib, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; hyprolose; croscarmellose sodium; lactose monohydrate; 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)

teva pharma australia pty ltd - dasatinib, quantity: 70 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hyprolose; lactose monohydrate; 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)

teva pharma australia pty ltd - dasatinib, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; hyprolose; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - imatinib - film-coated tablet - 100 milligram(s) - imatinib

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - imatinib - film-coated tablet - 400 milligram(s) - imatinib

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - imatinib mesilate - film-coated tablet - 100 milligram(s) - protein kinase inhibitors; imatinib