Pirfenidone axunio (previously Pirfenidone AET) (pirfenidone)
Generic
- Region
- 🇪🇺 EU
- Active substance
- pirfenidone
- Company
- Axunio Pharma GmbH
- Status
- Authorised
- Therapeutic area
- Idiopathic Pulmonary Fibrosis
- CHMP opinion
- Fri 22 Apr 2022
- EU approval
- Mon 20 Jun 2022
- Designations
- Generic
- Application
- EMEA/H/C/005873
- ATC
- L04AX05
- Official record
- www.ema.europa.eu
Indication
Pirfenidone AET 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 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.