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

puma biotechnology, inc. - neratinib maleate (unii: 9rm7xy23zs) (neratinib - unii:jjh94r3pwb) - neratinib 40 mg - nerlynx as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (her2)-positive breast cancer, to follow adjuvant trastuzumab based therapy [see clinical studies ( 14.1)] . nerlynx in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic her2-positive breast cancer who have received two or more prior anti-her2 based regimens in the metastatic setting [see clinical studies ( 14.2)] . none. risk summary based on findings from animal studies and the mechanism of action, nerlynx can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of neratinib to pregnant rabbits during organogenesis resulted in abortions, embryo-fetal death and fetal abnormalities in rabbits at

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

zuellig pharma sdn bhd - neratinib maleate -

Canada - English - Health Canada

knight therapeutics inc. - neratinib (neratinib maleate) - tablet - 40mg - neratinib (neratinib maleate) 40mg - antineoplastic agents

Israel - English - Ministry of Health

medison pharma ltd - neratinib as maleate - tablets - neratinib as maleate 40 mg - neratinib - nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive her2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy."nerlynx in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic her2-positive breast cancer who have received two or more prior anti-her2 based regimens in the metastatic setting.

New Zealand - English - Medsafe (Medicines Safety Authority)

specialised therapeutics limited - neratinib maleate 48.31mg equivalent to neratinib 40 mg - film coated tablet - 40 mg - active: neratinib maleate 48.31mg equivalent to neratinib 40 mg excipient: colloidal silicon dioxide crospovidone opadry ii red 85f15443 magnesium stearate mannitol microcrystalline cellulose povidone purified water - indicated for the extended adjuvant treatment of adult patients with early-stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

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

specialised therapeutics pm pty ltd - neratinib maleate, quantity: 48.31 mg (equivalent: neratinib, qty 40 mg) - tablet, film coated - excipient ingredients: magnesium stearate; crospovidone; titanium dioxide; macrogol 3350; mannitol; polyvinyl alcohol; povidone; colloidal anhydrous silica; purified water; microcrystalline cellulose; iron oxide red; purified talc - nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (her2)-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

Singapore - English - HSA (Health Sciences Authority)

specialised therapeutics asia pte ltd - neratinib maleate eqv neratinib - tablet, film coated - neratinib maleate eqv neratinib 40 mg

European Union - English - EMA (European Medicines Agency)

pierre fabre medicament - neratinib - breast neoplasms - antineoplastic agents - nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive her2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.

Kenya - English - Pharmacy and Poisons Board

beacon medicare limited 9/b/2,toyenbee circular - neratinib maleate - film-coated tablet - 40mg of neratinib maleate - other antineoplastic agents: protein kinase

Bangladesh - English - DGDA (Directorate General of Drug Administration)

beacon pharmaceuticals plc - neratinib - tablet - 40 mg