Pirfenidone Viatris (pirfenidone)
Generic
- Region
- 🇪🇺 EU
- Active substance
- pirfenidone
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
- CHMP opinion
- Thu 10 Nov 2022
- EU approval
- Tue 10 Jan 2023
- Designations
- Generic
- Application
- EMEA/H/C/005862
- ATC
- L04AX05
- Official record
- www.ema.europa.eu
Indication
Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Esbriet Authorised · H.A.C. Pharma
- 🇪🇺 Pirfenidone axunio (previously Pirfenidone AET) Authorised · Axunio Pharma 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.