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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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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Ofev : EPAR - Risk-management-plan summary (PDF/115.61 KB)
First published: 13/02/2015
Last updated: 25/01/2021
This EPAR was last updated on 25/01/2021
Authorisation details
Product details | |
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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 | |
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Marketing-authorisation holder |
Boehringer Ingelheim International GmbH
|
Revision |
17
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Date of issue of marketing authorisation valid throughout the European Union |
14/01/2015
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Contact address |
Product information
07/01/2021 Ofev - EMEA/H/C/003821 - PSUSA/00010319/202004
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Therapeutic indication
Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).