Episalvan
birch bark extract
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Episalvan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Episalvan.
For practical information about using Episalvan, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Episalvan : EPAR - Summary for the public (PDF/74.23 KB)
First published: 05/02/2016
Last updated: 05/02/2016
EMA/785623/2015 -
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Episalvan : EPAR - Risk-management-plan summary (PDF/45.74 KB)
First published: 05/02/2016
Last updated: 05/02/2016
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 |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
14/01/2016
|
Contact address |
Streiflingsweg 11
75223 Niefern-Oschelbronn Germany |
Product information
17/09/2020 Episalvan - EMEA/H/C/003938 - R/0018
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.