Is Tepotinib 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 Tepotinib, including Tepmetko (225 mg, Coated tablet, SAR 38095.40).

Is Tepotinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Tepotinib, including TEPMETKO (Prescription).

Is Tepotinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tepotinib: Tepmetko.

Are there safety signals or safety updates for Tepotinib?

US FDA: 1 entry (latest 2024-02-15).

Active substance

Tepotinib

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Tepmetko	225 mg	Coated tablet · Oral use	60 Blister	SAR 38095.40	NCE · Prescription	Merck Healthcare KGAA	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
TEPMETKO	EQ 225MG BASE	tablet · oral	EMD SERONO INC	Prescription	3 Feb 2021

EMA European Union — centrally authorised medicines

Tepmetko Merck Europe B.V. · Authorised · authorised 16 Feb 2022 · ATC L01EX21

Therapeutic indication (EMA)

Tepmetko 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
TEPMETKO	02516322	225 MG	TABLET · ORAL	EMD SERONO, A DIVISION OF EMD INC., CANADA

Safety signals and safety-related labeling changes

US FDA 15 Feb 2024 TEPMETKO — 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

All safety entries for tepotinib →

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.