European Union - English - 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.,

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

abg pharma sdn bhd - imatinib mesylate -

Singapore - English - HSA (Health Sciences Authority)

hetero singapore pte. ltd. - imatinib mesylate (form-α) eqv imatinib - tablet, film coated - imatinib mesylate (form-α) eqv imatinib 100.00mg

Singapore - English - HSA (Health Sciences Authority)

hetero singapore pte. ltd. - imatinib mesylate (form-α) eqv imatinib - tablet, film coated - imatinib mesylate (form-α) eqv imatinib 400.00mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaforte (malaysia) sdn. bhd. - imatinib mesylate -

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 119.5mg equivalent to imatinib base 100 mg;   - film coated tablet - 100 mg - active: imatinib mesilate 119.5mg equivalent to imatinib base 100 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new 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. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - imatinib mesilate 119.47mg equivalent to imatinib 100 mg;   - capsule - 100 mg - active: imatinib mesilate 119.47mg equivalent to imatinib 100 mg   excipient: crospovidone gelatin iron oxide red iron oxide yellow lactose monohydrate magnesium stearate titanium dioxide - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - imatinib mesilate 477.88mg equivalent to imatinib 400 mg;   - capsule - 400 mg - active: imatinib mesilate 477.88mg equivalent to imatinib 400 mg   excipient: crospovidone gelatin iron oxide black iron oxide red iron oxide yellow lactose monohydrate magnesium stearate titanium dioxide - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - imatinib - film-coated tablet - imatinib 100 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - imatinib - film-coated tablet - imatinib 400 mg - antineoplastic agents