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

specialised therapeutics alim pty ltd - pemigatinib, quantity: 9 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a - pemigatinib has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

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

specialised therapeutics alim pty ltd - pemigatinib, quantity: 4.5 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a - pemigatinib has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

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

specialised therapeutics alim pty ltd - pemigatinib, quantity: 13.5 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a - pemigatinib has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

European Union - English - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hydrochloride - vomiting; neoplasms; nausea; cancer - antiemetics and antinauseants, - akynzeo is indicated in adults for the:prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Canada - English - Health Canada

janssen inc - erdafitinib - tablet - 3mg - erdafitinib 3mg - antineoplastic agents

Canada - English - Health Canada

janssen inc - erdafitinib - tablet - 4mg - erdafitinib 4mg - antineoplastic agents

Canada - English - Health Canada

janssen inc - erdafitinib - tablet - 5mg - erdafitinib 5mg - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

arrotex pharmaceuticals (nz) limited - atomoxetine hydrochloride 11.4mg equivalent to atomoxetine 10 mg - capsule - 10 mg - active: atomoxetine hydrochloride 11.4mg equivalent to atomoxetine 10 mg excipient: gelatin   starch tekprint black sw-9008 tekprint black sw-9009 titanium dioxide   water   - indicated for the treatment of attention deficit/hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

New Zealand - English - Medsafe (Medicines Safety Authority)

arrotex pharmaceuticals (nz) limited - atomoxetine hydrochloride 114mg equivalent to atomoxetine 100 mg - capsule - 100 mg - active: atomoxetine hydrochloride 114mg equivalent to atomoxetine 100 mg excipient: gelatin   iron oxide red   iron oxide yellow   starch tekprint black sw-9008 tekprint black sw-9009 titanium dioxide   water   - indicated for the treatment of attention deficit/hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

New Zealand - English - Medsafe (Medicines Safety Authority)

arrotex pharmaceuticals (nz) limited - atomoxetine hydrochloride 20.5mg equivalent to atomoxetine 18 mg - capsule - 18 mg - active: atomoxetine hydrochloride 20.5mg equivalent to atomoxetine 18 mg excipient: gelatin   iron oxide yellow starch tekprint black sw-9008 tekprint black sw-9009 titanium dioxide   water   - indicated for the treatment of attention deficit/hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.