Episalvan

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birch bark extract

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 15/06/2018

Authorisation details

Product details
Name
Episalvan
Agency product number
EMEA/H/C/003938
Active substance
betulae cortex dry extract  (5-10 : 1); extraction solvent: n-heptane 95% (w/w)
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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Amryt AG
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
14/01/2016
Contact address
Streiflingsweg 11
75223 Niefern-Oschelbronn
Germany

Product information

30/05/2018 Episalvan - EMEA/H/C/003938 - IB/0009

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Preparation 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.

Assessment history

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