This medicine is authorised for use in the European Union.


Tabrecta is a medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the cancer is advanced and its cells have particular genetic mutations (changes) leading to ‘mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping’. This means that the cancer cells make an abnormal form of a protein called MET, because a part of the MET gene known as exon 14 is not used.

Tabrecta is used when the patient needs further treatment after receiving immunotherapy or platinum-based chemotherapy, or both.

Tabrecta contains the active substance capmatinib.

This EPAR was last updated on 25/01/2023

Authorisation details

Product details
Agency product number
Active substance
capmatinib dihydrochloride monohydrate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
D04 A9N6 

Product information

01/12/2022 Tabrecta - EMEA/H/C/004845 - II/0002

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

How useful was this page?

Add your rating
1 rating