Is Capmatinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Capmatinib, including TABRECTA (Prescription).

Is Capmatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Capmatinib: Tabrecta.

Are there safety signals or safety updates for Capmatinib?

US FDA: 1 entry (latest 2024-03-14).

Active substance

Capmatinib

US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
TABRECTA	EQ 150MG BASE; EQ 200MG BASE	tablet · oral	NOVARTIS PHARM	Prescription	6 May 2020

EMA European Union — centrally authorised medicines

Tabrecta Novartis Europharm Limited · Authorised · authorised 20 Jun 2022 · ATC L01EX17

Therapeutic indication (EMA)

Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TABRECTA	02527391	150 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
TABRECTA	02527405	200 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 14 Mar 2024 TABRECTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for capmatinib →

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.