Írsko - angličtina - HPRA (Health Products Regulatory Authority)

teva b.v. - dasatinib - film-coated tablet - 70 milligram(s) - dasatinib

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - imatinib mesilate, quantity: 478 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - imatinib mesilate, quantity: 119.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - imatinib mesilate, quantity: 119.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - imatinib mesilate, quantity: 478 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red - imatinib rbx is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - dasatinib, quantity: 70 mg - tablet, film coated - excipient ingredients: triethyl citrate; hypromellose; colloidal anhydrous silica; hyprolose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; ethylcellulose; titanium dioxide - dasatinib arx 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 ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - dasatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: triethyl citrate; lactose monohydrate; hypromellose; hyprolose; colloidal anhydrous silica; titanium dioxide; croscarmellose sodium; ethylcellulose; microcrystalline cellulose; magnesium stearate - dasatinib arx 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 ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - dasatinib, quantity: 20 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; triethyl citrate; lactose monohydrate; hyprolose; microcrystalline cellulose; colloidal anhydrous silica; hypromellose; titanium dioxide; magnesium stearate; ethylcellulose - dasatinib arx 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 ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - dasatinib, quantity: 50 mg - tablet, film coated - excipient ingredients: ethylcellulose; hyprolose; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; hypromellose; titanium dioxide; lactose monohydrate; magnesium stearate; triethyl citrate - dasatinib arx 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 ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy

Európska únia - angličtina - 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.,