Tabrecta
capmatinib
Table of contents
Overview
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.
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Tabrecta : EPAR - Medicine Overview (PDF/114.05 KB)
First published: 21/09/2022
EMA/240009/2022 -
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Tabrecta : EPAR - Risk management plan summary (PDF/67.36 KB)
First published: 21/09/2022
Authorisation details
Product details | |
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Name |
Tabrecta
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Agency product number |
EMEA/H/C/004845
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Active substance |
capmatinib dihydrochloride monohydrate
|
International non-proprietary name (INN) or common name |
capmatinib
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
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Anatomical therapeutic chemical (ATC) code |
L01EX17
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Additional 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 | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
20/06/2022
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Contact address |
Vista Building |
Product information
01/12/2022 Tabrecta - EMEA/H/C/004845 - II/0002
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.