Ofev (nintedanib)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- nintedanib
- Company
- Boehringer Ingelheim International GmbH
- Status
- Authorised
- Therapeutic area
- Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Pulmonary Fibrosis; Scleroderma, Systemic
- CHMP opinion
- Thu 20 Nov 2014
- EU approval
- Wed 14 Jan 2015
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/003821
- ATC
- L01EX09
- Official record
- www.ema.europa.eu
Indication
Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Nintedanib Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Vargatef Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Nintedanib Viatris Authorised · Viatris Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.