Episalvan (birch bark extract)
- Region
- 🇪🇺 EU
- Active substance
- birch bark extract
- Company
- Amryt AG
- Status
- Withdrawn
- Therapeutic area
- Wounds and Injuries; Wound Healing
- CHMP opinion
- Thu 19 Nov 2015
- EU approval
- Thu 14 Jan 2016
- Application
- EMEA/H/C/003938
- ATC
- D03AX13
- Official record
- www.ema.europa.eu
Indication
Treatment of partial thickness wounds in adults. See sections 4.4 and 5.1 in Product Information with respect to type of wounds studied.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Filsuvez Authorised · Chiesi Farmaceutici S.p.A
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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.