Ofev

RSS

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 Ofev. 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 Ofev.

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

This EPAR was last updated on 02/08/2018

Authorisation details

Product details
Name
Ofev
Agency product number
EMEA/H/C/003821
Active substance
nintedanib
International non-proprietary name (INN) or common name
nintedanib
Therapeutic area (MeSH)
Idiopathic Pulmonary Fibrosis
Anatomical therapeutic chemical (ATC) code
L01XE
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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
15/01/2015
Contact address
Binger Strasse 173 55216
Ingelheim am Rhein
Germany

Product information

26/07/2018 Ofev - EMEA/H/C/003821 - PSUSA/00010319/201710

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Assessment history

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