Scenesse (afamelanotide)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- afamelanotide
- Company
- Clinuvel Europe Limited
- Status
- Authorised
- Therapeutic area
- Protoporphyria, Erythropoietic
- CHMP opinion
- Thu 23 Oct 2014
- EU approval
- Mon 22 Dec 2014
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/002548
- ATC
- D02BB02
- Official record
- www.ema.europa.eu
Indication
Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Regulatory milestones
No milestones recorded in the last year.
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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.