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)

juno pharmaceuticals pty ltd - imatinib mesilate -

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

juno pharmaceuticals pty ltd - imatinib mesilate -

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

takeda pharmaceuticals australia pty ltd - pantoprazole, quantity: 22.57 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: iron oxide yellow; povidone; polysorbate 80; crospovidone; purified water; hypromellose; titanium dioxide; sodium carbonate; sodium lauryl sulfate; triethyl citrate; propylene glycol; mannitol; methacrylic acid copolymer; calcium stearate; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - somac heartburn relief is indicated for symptomatic relief of heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux disease (gord).

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

ferring pharmaceuticals pty ltd - budesonide, quantity: 9 mg - tablet, modified release - excipient ingredients: stearic acid; lecithin; microcrystalline cellulose; hyprolose; lactose monohydrate; silicon dioxide; magnesium stearate; methacrylic acid copolymer; purified talc; titanium dioxide; triethyl citrate - cortiment prolonged-release tablets are indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (uc) where 5-asa treatment is not sufficient or not tolerated.

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

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 2 mg - tablet, uncoated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; hyprolose; lactose monohydrate; iron oxide yellow; microcrystalline cellulose; maize starch; indigo carmine aluminium lake - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

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

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 5 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; indigo carmine aluminium lake; maize starch; colloidal anhydrous silica; hyprolose; magnesium stearate - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

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

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 5 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; hyprolose; indigo carmine aluminium lake; microcrystalline cellulose; maize starch; magnesium stearate - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

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

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 15 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; hyprolose; magnesium stearate; maize starch; microcrystalline cellulose - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.