Irska - angleščina - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - imatinib mesilate - film-coated tablet - 100 milligram(s) - protein kinase inhibitors; imatinib

Irska - angleščina - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - imatinib mesilate - film-coated tablet - 400 milligram(s) - protein kinase inhibitors; imatinib

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - imatinib mesilate 477.877mg equivalent to imatinib 400 mg;   - film coated tablet - 400 mg - active: imatinib mesilate 477.877mg equivalent to imatinib 400 mg   excipient: calcium hydrogen phosphate crospovidone magnesium stearate opadry butterscotch 85f97369 purified water - - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml) (for paediatric use see section 4.2). - treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for paediatric use see section 4.2).

Evropska unija - angleščina - 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. 

Irska - angleščina - HPRA (Health Products Regulatory Authority)

generics (uk) limited - imatinib mesilate - film-coated tablet - 100 milligram(s)

Irska - angleščina - HPRA (Health Products Regulatory Authority)

generics (uk) limited - imatinib - film-coated tablet - 400 milligram(s)

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

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

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

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

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

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

Avstralija - angleščina - 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.