Episalvan
Withdrawn
birch bark extract
Medicine
Human
Withdrawn
On 7 June 2022, the European Commission withdrew the marketing authorisation for Episalvan (birch bark extract) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amryt GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Episalvan was granted marketing authorisation in the EU on 14 January 2016 for the treatment of partial thickness wounds in adults.
The European Public Assessment Report (EPAR) for Episalvan is updated to indicate that the marketing authorisation is no longer valid.
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
Treatment of partial thickness wounds in adults. See sections 4.4 and 5.1 in Product Information with respect to type of wounds studied.