Episalvan
birch bark extract
Table of contents
Overview
The marketing authorisation for Episalvan has been withdrawn at the request of the marketing-authorisation holder.
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List item
Episalvan : EPAR - Summary for the public (PDF/247.82 KB)
First published: 05/02/2016
Last updated: 15/07/2022
EMA/785623/2015 -
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List item
Episalvan : EPAR - Risk-management-plan summary (PDF/225.92 KB)
First published: 05/02/2016
Last updated: 15/07/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Episalvan
|
| Agency product number |
EMEA/H/C/003938
|
| Active substance |
Betulae cortex
|
| International non-proprietary name (INN) or common name |
birch bark extract
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
D03AX13
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Amryt AG
|
| Revision |
7
|
| Date of issue of marketing authorisation valid throughout the European Union |
14/01/2016
|
| Contact address |
Streiflingsweg 11
75223 Niefern-Oschelbronn Germany |
Product information
07/06/2022 Episalvan - EMEA/H/C/003938 -
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Preparations for treatment of wounds and ulcers
Therapeutic 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.