Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - imatinib - film-coated tablet - imatinib 200 mg - antineoplastic agents

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - imatinib - film-coated tablet - imatinib 300 mg - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - imatinib mesilate 478mg equivalent to imatinib base 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib base 400 mg excipient: colloidal silicon dioxide crospovidone hyprolose hypromellose iron oxide red iron oxide yellow macrogol 400 magnesium stearate microcrystalline cellulose povidone purified talc purified water - - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) (for paediatric use see section dosage and administration). - treatment of adult and paediatric patients with ph+ cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy (for paediatric use see section dosage and administration).

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

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - imatinib mesilate 478mg equivalent to imatinib free base 400 mg - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib free base 400 mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry beige 85f97378 - imatinib mylan is indicated for the: - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) - treatment of adult and paediatric patients with ph+ cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - imatinib mesilate - film coated tablet - 400 milligram - protein kinase inhibitors

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - imatinib mesilate - film coated tablet - 100 milligram - protein kinase inhibitors

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

takeda pharmaceuticals australia pty ltd - ponatinib hydrochloride, quantity: 48.1 mg (equivalent: ponatinib, qty 45 mg) - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate; lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - iclusig is indicated for the treatment of adult patients with:,chronic phase (cp), accelerated phase (ap), or blast phase (bp) chronic myeloid ieukaemia (cml) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a t315i mutation.,philadelphia chromosome positive acute lymphoblastic ieukaemia (ph+ all) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a t315i mutation.,therapy with iclusig should be initiated and monitored by a haematologist with expertise in managing adult ieukaemias.

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

takeda pharmaceuticals australia pty ltd - ponatinib hydrochloride, quantity: 16 mg (equivalent: ponatinib, qty 15 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - iclusig is indicated for the treatment of adult patients with:,chronic phase (cp), accelerated phase (ap), or blast phase (bp) chronic myeloid ieukaemia (cml) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a t315i mutation.,philadelphia chromosome positive acute lymphoblastic ieukaemia (ph+ all) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a t315i mutation.,therapy with iclusig should be initiated and monitored by a haematologist with expertise in managing adult ieukaemias.

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

pharmacor pty ltd - imatinib mesilate, quantity: 119.5 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - gilmat 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 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).