Tevimbra

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tislelizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Tevimbra is a cancer medicine used to treat adults with squamous oesophageal cancer (cancer of the oesophagus, the passage from the mouth to the stomach) if the cancer is advanced, has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). It is used after cancer treatment with platinum-based medicines has not worked well enough.

Oesophageal cancer is rare, and Tevimbra was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 13 November 2020. Further information on the orphan designation can be found on the EMA website.

Tevimbra contains the active substance tislelizumab.

This EPAR was last updated on 10/10/2023

Authorisation details

Product details
Name
Tevimbra
Agency product number
EMEA/H/C/005919
Active substance
Tislelizumab
International non-proprietary name (INN) or common name
tislelizumab
Therapeutic area (MeSH)
Esophageal Squamous Cell Carcinoma
Anatomical therapeutic chemical (ATC) code
L01FF09
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
15/09/2023
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

Tevimbra - EMEA/H/C/005919 -

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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

Oesophageal squamous cell carcinoma (OSCC) Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Assessment history

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