Ofev

RSS

nintedanib

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

Overview

Ofev is a medicine used to treat adults with:

  • idiopathic pulmonary fibrosis (IPF), a disease of unknown cause in which fibrous tissue forms in the lungs;
  • systemic sclerosis associated interstitial lung disease, a disease in which the immune system (the body’s natural defences) is overactive, causing production of fibrous tissue and progressive scarring of the lungs;
  • other chronic fibrosing interstitial lung diseases which are progressive.

Ofev contains the active substance nintedanib.

This EPAR was last updated on 28/07/2020

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
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address
Binger Strasse 173 55216
Ingelheim am Rhein
Germany

Product information

13/07/2020 Ofev - EMEA/H/C/003821 - II/0027

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

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

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating
1 rating