NERLYNX

This brand name is authorized in Austria, Canada, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States

Active ingredients

The drug NERLYNX contains one active pharmaceutical ingredient (API):

1 Neratinib UNII 9RM7XY23ZS - NERATINIB MALEATE ANHYDROUS

Neratinib is an irreversible pan–erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3). This results in sustained inhibition of these growth promoting pathways with HER2-amplified or over-expressed, or HER2-mutant breast cancers. Read about Neratinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
NERLYNX Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
NERLYNX Film-coated tablet	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L01EH02		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EH Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
Discover more medicines within L01EH02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02490536
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 5345-MEE-0720
Country: EE	Ravimiamet	Identifier(s): 1778991
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 181310
Country: FR	Base de données publique des médicaments	Identifier(s): 69627592
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 378569
Country: HK	Department of Health Drug Office	Identifier(s): 66416
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8305
Country: IT	Agenzia del Farmaco	Identifier(s): 046987018
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1086200
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 202762
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 20851
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100410717
Country: SG	Health Sciences Authority	Identifier(s): 15861P
Country: US	FDA, National Drug Code	Identifier(s): 70437-240