ALECENSA

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

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 more about Alectinib

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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