Vargatef
nintedanib
Table of contents
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.
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List item
Vargatef : EPAR - Summary for the public (PDF/76.64 KB)
First published: 08/01/2015
Last updated: 08/01/2015
EMA/601036/2014 -
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Vargatef : EPAR - Risk-management-plan summary (PDF/125.09 KB)
First published: 08/01/2015
Last updated: 08/03/2021
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:
- 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
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.