Is Entrectinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Entrectinib, including Rozlytrek (100 mg, Capsule, hard, SAR 3444.35); Rozlytrek (200 mg, Capsule, hard, SAR 20653.45).

Is Entrectinib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Entrectinib, including ROZLYTREK (Prescription); ROZLYTREK (Prescription); ROZLYTREK (Prescription).

Is Entrectinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Entrectinib: Rozlytrek.

Are there safety signals or safety updates for Entrectinib?

EMA PRAC: 1 entry; US FDA: 2 entries (latest 2026-10-01).

Active substance

Entrectinib

SFDA 2
US FDA 3
EMA 1
Health Canada 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Rozlytrek	100 mg	Capsule, hard · Oral use	30 Bottle	SAR 3444.35	NCE · Prescription	F.Hoffmann-La Roche Ltd.	Valid
Rozlytrek	200 mg	Capsule, hard · Oral use	90 Bottle	SAR 20653.45	NCE · Prescription	F.Hoffmann-La Roche Ltd.	Valid

Indications — CHI Daman Drug Formulary

BRAIN CANCERS; Cervical Cancer; COLORECTAL CANCER-ADVANCED/ METASTATIC; GASTRIC CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; NEUROENDOCRINE TUMORS; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; SOFT TISSUE SARCOMA; THYROID CANCER; VAGINAL AND VULVAR CANCERS

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

Product	Strength	Form · route	Applicant	Status	First approved
ROZLYTREK	100MG; 200MG	capsule · oral	GENENTECH INC	Prescription	15 Aug 2019
ROZLYTREK	100MG; 200MG	capsule · oral	GENENTECH INC	Prescription	15 Aug 2019
ROZLYTREK	50MG/PACKET	pellets · oral	GENENTECH INC	Prescription	20 Oct 2023

EMA European Union — centrally authorised medicines

Rozlytrek Roche Registration GmbH · Authorised · authorised 31 Jul 2020 · ATC L01EX14

Therapeutic indication (EMA)

Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ROZLYTREK	02495007	100 MG	CAPSULE · ORAL	HOFFMANN-LA ROCHE LIMITED
ROZLYTREK	02495015	200 MG	CAPSULE · ORAL	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 1 Oct 2026 ROZLYTREK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 1 Oct 2026 ROZLYTREK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 7 Mar 2024 PRAC signal: Myocarditis
Action for MAH: update of the product information: No

All safety entries for entrectinib →

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.