Episalvan
Withdrawn
This medicine's authorisation has been withdrawn
birch bark extract
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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The European Public Assessment Report (EPAR) for Episalvan is updated to indicate that the marketing authorisation is no longer valid.
Product information
07/06/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Episalvan
- Active substance
- Betulae cortex
- International non-proprietary name (INN) or common name
- birch bark extract
- Therapeutic area (MeSH)
- Wounds and Injuries
- Wound Healing
- Anatomical therapeutic chemical (ATC) code
- D03AX13
Pharmacotherapeutic group
Preparations for treatment of wounds and ulcersTherapeutic 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.
Assessment history
News on Episalvan
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