Malesia - Kiingereza - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pahang pharmacy sdn. bhd. - levonorgestrel -

Marekani - Kiingereza - NLM (National Library of Medicine)

grifols usa, llc - .alpha.1-proteinase inhibitor human (unii: f43i396ois) (.alpha.1-proteinase inhibitor human - unii:f43i396ois) - .alpha.1-proteinase inhibitor human 1000 mg in 20 ml - prolastin® -c liquid is an alpha1 -proteinase inhibitor (human) (alpha1 -pi) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1 -pi (alpha1 -antitrypsin deficiency). limitations of use - the effect of augmentation therapy with any alpha1 -pi, including prolastin-c liquid, on pulmonary exacerbations and on the progression of emphysema in alpha1 -pi deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.    - clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with prolastin-c liquid are not available. - prolastin-c liquid is not indicated as therapy for lung disease in patients in whom severe alpha1 -pi deficiency has not been established. prolastin-c liquid is contraindicated in: - iga deficient patients with antibodies against iga, due to the risk of severe hypersensitivity. - patients with a history of anaphylaxis or other sever

Australia - Kiingereza - 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 - Kiingereza - 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 - Kiingereza - 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).

Umoja wa Ulaya - Kiingereza - 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.

Kanada - Kiingereza - Health Canada

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

Kanada - Kiingereza - Health Canada

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

Kanada - Kiingereza - Health Canada

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

Nyuzilandi - Kiingereza - 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.