Singapore - English - HSA (Health Sciences Authority)

roche singapore pte. ltd. - alectinib hydrochloride 161.33 mg eqv. alectinib - capsule - alectinib hydrochloride 161.33 mg eqv. alectinib 150 mg

Canada - English - Health Canada

novartis pharmaceuticals canada inc - ceritinib - capsule - 150mg - ceritinib 150mg - antineoplastic agents

United States - English - NLM (National Library of Medicine)

ariad pharmaceuticals inc. - brigatinib (unii: hyw8db273j) (brigatinib - unii:hyw8db273j) - brigatinib 30 mg - alunbrig is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc) who have progressed on or are intolerant to crizotinib. this indication is approved under accelerated approval based on tumor response rate and duration of response [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. none. risk summary based on its mechanism of action and findings in animals, alunbrig can cause fetal harm when administered to a pregnant woman [see data and clinical pharmacology (12.1)] . there are no clinical data on the use of alunbrig in pregnant women. administration of brigatinib to pregnant rats during the period of organogenesis resulted in dose-related skeletal anomalies at doses as low as 12.5 mg/kg/day (approximately 0.7 times the human exposure by auc at 180 mg once daily) as well as increased post-implantation loss, malformatio

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - lorlatinib - film coated tablets - lorlatinib 25 mg - lorlatinib - lorviqua is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk) positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - lorlatinib - film coated tablets - lorlatinib 100 mg - lorlatinib - lorviqua is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk) positive.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pfizer (malaysia) sdn. bhd. - lorlatinib -

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

takeda pharmaceuticals australia pty ltd - brigatinib, quantity: 180 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; hydrophobic colloidal silica anhydrous; lactose monohydrate; sodium starch glycollate type a; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc).

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

takeda pharmaceuticals australia pty ltd - brigatinib, quantity: 90 mg - tablet, film coated - excipient ingredients: hydrophobic colloidal silica anhydrous; microcrystalline cellulose; sodium starch glycollate type a; magnesium stearate; lactose monohydrate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc).

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

takeda pharmaceuticals australia pty ltd - brigatinib, quantity: 30 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; hydrophobic colloidal silica anhydrous; sodium starch glycollate type a; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc).

Israel - English - Ministry of Health

abic marketing ltd, israel - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - irinotecan hydrochloride trihydrate 20 mg/ml - irinotecan - * for the treatment of patients with metastatic colorectal cancer: - in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease. - as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. * for the treatment of patients with small cell lung cancer.* for the treatment of patients with gastric cancer.* irinotecan in combination with leucovorin, oxaliplatin and 5-fluorouracil, for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.