EU CHMP recommends approval of Episalvan (birch bark extract) for wound healing- Birken AG
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Episalvan (birch bark extract), from Birken AG, intended for the treatment of partial thickness wounds in adults.
The active substance of Episalvan is birch bark extract (as dry extract, refined) from Betula pendula Roth/Betula pubescens Ehrh., corresponding to 72-88 mg betulin. It is thought to work by modulating several pro-inflammatory mediators in the first days of wound healing and by helping keratinocytes to restore the damaged skin epithelial tissue. The benefits with Episalvan are its ability to reduce the healing time of wounds where the upper layers of the skin have been damaged, for example by a burn or during surgical skin grafting. The most common side effects are itching and pain in the area where the product is applied and complications in the wound healing process.
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