Nintedanib Viatris (nintedanib)
- Region
- 🇪🇺 EU
- Active substance
- nintedanib
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Pulmonary Fibrosis
- CHMP opinion
- Thu 19 Jun 2025
- EU approval
- Fri 22 Aug 2025
- Designations
- Generic
- Application
- EMEA/H/C/006486
- ATC
- L01EX09
- Official record
- www.ema.europa.eu
Indication
Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Viatris is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Viatris is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ofev Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Nintedanib Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Vargatef Authorised · Boehringer Ingelheim International GmbH
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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.