Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - imatinib - film-coated tablet - 400 milligram(s) - other antineoplastic agents - antineoplastic agents, protein kinase inhibitor - imatinib clonmel is indicated in:
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.

Malta - English - Medicines Authority

aqvida gmbh - imatinib - hard capsule - imatinib 100 mg - antineoplastic agents

Malta - English - Medicines Authority

aqvida gmbh - imatinib - hard capsule - imatinib 200 mg - antineoplastic agents

Malta - English - Medicines Authority

aqvida gmbh - imatinib - hard capsule - imatinib 400 mg - antineoplastic agents

Malta - English - Medicines Authority

boston biopharma limited malta life sciences park, building 2, level 0, san gwann sgn 3000, malta - imatinib - hard capsule - imatinib 400 mg - antineoplastic agents

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

cipla australia pty ltd - imatinib mesilate, quantity: 59.75 mg (equivalent: imatinib, qty 50 mg) - capsule - excipient ingredients: lactose; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified water; gelatin - imatinib capsules indicated for: - 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/myeloproflierative 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) - adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp)

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

cipla australia pty ltd - imatinib mesilate, quantity: 59.75 mg (equivalent: imatinib, qty 50 mg) - capsule - excipient ingredients: lactose; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified water; gelatin - imatinib capsules indicated for: - 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/myeloproflierative 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) - adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp)

Malta - English - Medicines Authority

1 a pharma gmbh keltenring 1+3, 82041 oberhaching, germany - imatinib mesilate - film-coated tablet - imatinib mesilate 100 mg - antineoplastic agents

Malta - English - Medicines Authority

1 a pharma gmbh keltenring 1+3, 82041 oberhaching, germany - imatinib mesilate - film-coated tablet - imatinib mesilate 400 mg - antineoplastic agents

Malta - English - Medicines Authority

rowex ltd newtown bantry, co. cork, , ireland - imatinib mesilate - film-coated tablet - imatinib mesilate 100 mg - antineoplastic agents