FILSUVEZ (Chiesi Australia Pty Ltd)
Product name
FILSUVEZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
134 (175 working days)
Active ingredients
birch bark dry extract (84-95 per cent) triterpenes
Registration type
NCE/NBE
Indication
Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.