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

roche products pty ltd - alectinib hydrochloride, quantity: 161.33 mg (equivalent: alectinib, qty 150 mg) - capsule, hard - excipient ingredients: magnesium stearate; potassium chloride; carmellose calcium; maize starch; carnauba wax; hypromellose; hyprolose; titanium dioxide; lactose monohydrate; sodium lauryl sulfate; carrageenan; iron oxide red; iron oxide yellow; indigo carmine aluminium lake; shellac; glyceryl monooleate - alecensa is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive, locally advanced or metastatic non-small cell lung cancer (nsclc).

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - alectinib hydrochloride 161.33mg equivalent to alectinib 150mg - capsule - 150 mg - active: alectinib hydrochloride 161.33mg equivalent to alectinib 150mg excipient: black ink (alecensa) carmellose calcium carnauba wax carrageenan hyprolose hypromellose lactose monohydrate magnesium stearate maize starch potassium chloride sodium laurilsulfate titanium dioxide - alecensa is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive, locally advanced or metastatic non-small cell lung cancer (nsclc).

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

genentech, inc. - alectinib hydrochloride (unii: p9yy73lo6j) (alectinib - unii:lij4ct1z3y) - alectinib 150 mg - alecensa is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc) as detected by an fda-approved test. none. risk summary based on animal studies and its mechanism of action, alecensa can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on alecensa use in pregnant women. administration of alectinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7 times those observed in humans treated with alectinib at 600 mg twice daily (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in a preliminary rabbit embryo-fetal study, adm

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

roche (malaysia) sdn. bhd. - alectinib hydrochloride -

Canada - English - Health Canada

hoffmann-la roche limited - alectinib (alectinib hydrochloride) - capsule - 150mg - alectinib (alectinib hydrochloride) 150mg - antineoplastic agents

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - alectinib as hydrochloride - capsules - alectinib as hydrochloride 150 mg - alectinib is indicated for the treatment of patients with alk positive, locally advanced or metastatic non-small cell lung cancer (nsclc) who progressed on or are intolerant to crizotinibalecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (alk)-positive advanced non-small cell lung cancer (nsclc).

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

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - alectinib hydrochloride - carcinoma, non-small-cell lung - antineoplastic agents - alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (alk)-positive advanced non-small cell lung cancer (nsclc).alecensa as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc previously treated with crizotinib.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - alectinib hydrochloride - capsule - 150mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

f. hoffmann-la roche ag - alectnib (alectinib hydrochloride) - capsules hard - 150mg