Ireland - English - HPRA (Health Products Regulatory Authority)

teva b.v. - abacavir; lamivudine - film-coated tablet - 600 mg/300 milligram(s) - antivirals for treatment of hiv infections, combinations; lamivudine and abacavir

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - abacavir; lamivudine - film-coated tablet - 600mg/300 milligram(s) - antivirals for treatment of hiv infections, combinations; lamivudine and abacavir

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

pharmacor pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 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).

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

pharmacor pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 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).

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - imatinib - film-coated tablet - 100 milligram(s) - other antineoplastic agents - protein-tyrosine kinase inhibitor - imatinib 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 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - imatinib - film-coated tablet - 400 milligram(s) - other antineoplastic agents - protein-tyrosine kinase inhibitor - imatinib 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 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. adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) an

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).

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).

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - lamivudine, zidovudine - film-coated tablet - lamivudine 150 mg zidovudine 300 mg - antivirals for systemic use

Malta - English - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - imatinib - film-coated tablet - imatinib 100 mg - antineoplastic agents