Is Alectinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Alectinib, including ALECENSA 150 Mg Capsule (150 mg, Capsule, SAR 23760.05).

Is Alectinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Alectinib, including ALECENSA (Prescription).

Is Alectinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Alectinib: Alecensa.

Are there safety signals or safety updates for Alectinib?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-08-14).

Active substance

Alectinib

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALECENSA 150 Mg Capsule	150 mg	Capsule · Oral use	224 Blister	SAR 23760.05	NCE · Prescription	ROCHE	Valid

Indications — CHI Daman Drug Formulary

NON-SMALL-CELL LUNG CARCINOMA (NSCLC); T-CELL LYMPHOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ALECENSA	EQ 150MG BASE	capsule · oral	HOFFMANN-LA ROCHE	Prescription	11 Dec 2015

EMA European Union — centrally authorised medicines

Alecensa Roche Registration GmbH · Authorised · authorised 16 Feb 2017 · ATC L01ED03

Therapeutic indication (EMA)

Adjuvant treatment of resected non small cell lung cancer (NSCLC) Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria).Treatment of advanced NSCLCAlecensa as monotherapy is indicated for the first line treatment of adult patients with ALK positive advanced NSCLC.Alecensa as monotherapy is indicated for the treatment of adult patients with ALK positive advanced NSCLC previously treated with crizotinib.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALECENSARO	02458136	150 MG	CAPSULE · ORAL	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 14 Aug 2026 ALECENSA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Nov 2018 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: No

All safety entries for alectinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.