Filsuvez (birch bark extract)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- birch bark extract
- Company
- Chiesi Farmaceutici S.p.A
- Status
- Authorised
- Therapeutic area
- Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
- CHMP opinion
- Fri 22 Apr 2022
- EU approval
- Tue 21 Jun 2022
- Designations
- Orphan
- Application
- EMEA/H/C/005035
- ATC
- D03AX13
- Official record
- www.ema.europa.eu
Indication
Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Episalvan Withdrawn · Amryt AG
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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.