Vargatef

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nintedanib

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

Overview

This is a summary of the European public assessment report (EPAR) for Vargatef. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vargatef.

For practical information about using Vargatef, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 07/12/2021

Authorisation details

Product details
Name
Vargatef
Agency product number
EMEA/H/C/002569
Active substance
nintedanib
International non-proprietary name (INN) or common name
nintedanib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XE3
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
21/11/2014
Contact address
Binger Strasse 173
55216 Ingelheim
Germany

Product information

18/11/2021 Vargatef - EMEA/H/C/002569 - IG/1463

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

Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.

Assessment history

Changes since initial authorisation of medicine

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