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.
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List item
Ofev : EPAR - Medicines overview (PDF/141.81 KB)
First published: 13/02/2015
Last updated: 28/07/2020
EMA/114463/2020 -
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List item
Ofev : EPAR - Risk Management Plan (PDF/2.39 MB)
First published: 26/06/2023
Last updated: 01/08/2023
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 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 |
24
|
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
28/07/2023 Ofev - EMEA/H/C/003821 - X/0052/G
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
Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).