Esbriet (pirfenidone)
- Region
- 🇪🇺 EU
- Active substance
- pirfenidone
- Company
- H.A.C. Pharma
- Status
- Authorised
- Therapeutic area
- Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
- CHMP opinion
- Thu 16 Dec 2010
- EU approval
- Mon 28 Feb 2011
- Application
- EMEA/H/C/002154
- ATC
- L04AX05
- Official record
- www.ema.europa.eu
Indication
Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pirfenidone Viatris Authorised · Viatris Limited
- 🇪🇺 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.