ALECENSA

This brand name is authorized in Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Alectinib UNII P9YY73LO6J - ALECTINIB HYDROCHLORIDE

Alectinib is a highly selective and potent ALK and rearranged during transfection (RET) tyrosine kinase inhibitor. In pre-clinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including signal transducer and activator of transcription 3 (STAT 3) and phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT) and induction of tumour cell death (apoptosis). Read about Alectinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ALECENSA Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
L01ED03		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01ED Anaplastic lymphoma kinase (ALK) inhibitors
Discover more medicines within L01ED03

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11226W
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 529219040027601
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 4434-MEE-1018
Country: EE	Ravimiamet	Identifier(s): 1739437, 1758708
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1161169001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 474675
Country: FR	Base de données publique des médicaments	Identifier(s): 60639892
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 341980, 383718
Country: HK	Department of Health Drug Office	Identifier(s): 64854
Country: IE	Health Products Regulatory Authority	Identifier(s): 88867
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7799
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291032M3021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1082317, 1088944
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 141844
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 19002
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100383860
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64294001
Country: SG	Health Sciences Authority	Identifier(s): 15220P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 6993241H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699505153407
Country: US	FDA, National Drug Code	Identifier(s): 50242-130
Country: ZA	Health Products Regulatory Authority	Identifier(s): 53/32.16/0183