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 11/04/2019

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
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
Boehringer Ingelheim International GmbH
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
21/11/2014
Contact address
Binger Strasse 173
55216 Ingelheim
Germany

Product information

08/02/2019 Vargatef - EMEA/H/C/002569 - IB/0024

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

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