Episalvan

birch bark extract

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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.

What is Episalvan and what is it used for?

Episalvan is a medicine used in adults to treat partial-thickness skin wounds. These are wounds where the upper layers of the skin have been lost, for example by a burn or during surgical skin grafting.

Episalvan contains a dry extract from birch bark.

How is Episalvan used?

Episalvan is available as a gel that should be applied as a thin layer (1 mm in thickness) to the wound, which should then be covered by a wound dressing. The gel should be re-applied with every dressing change, until the wound is healed, for up to 4 weeks.

The medicine can only be obtained with a prescription.

How does Episalvan work?

The exact way Episalvan works is not fully understood. It is thought that the active substance in Episalvan, birch bark extract, helps the cells that make up the outer layer of the skin (keratinocytes) grow and move quickly towards the gap created by the wound, therefore helping wounds to heal faster.

What benefits of Episalvan have been shown in studies?

Episalvan was studied in two main studies involving 217 patients with partial-thickness skin wounds in patients who underwent skin graft surgery. The patients received Episalvan together with wound dressing on one half of the wound, while the other half of the wound was treated with standard wound dressing only. In the first study, the average time from surgery to wound closure was 17.1 days for the wounds treated with standard wound dressing only and 15.5 days for the wounds also treated with Episalvan. The respective times were 16.0 and 15.1 days respectively in the second study.

A third study involved 57 patients with partial-thickness burn wounds who had half their wound treated with Episalvan and the other half with a standard disinfectant gel. Both wound halves were also covered with a wound dressing. The average time to wound closure was 8.8 days for the wounds treated with standard disinfectant gel and 7.6 days for the wounds treated with Episalvan.

What are the risks associated with Episalvan?

The most common side effects with Episalvan are wound complications, pain in the skin (both of which may affect more than 3 in 100 people) and pruritus (itching) (which may affect more 1 in 100 people).

For the full list of all side effects and restrictions reported with Episalvan, see the package leaflet.

Why is Episalvan approved?

Episalvan gel was shown to reduce wound healing times. Although the differences were small they were considered relevant for patients with partial-thickness wounds, which can be difficult to heal and for which treatment options are limited. With regard to safety, no major issues were identified and side effects were manageable. The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Episalvan’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Episalvan?

A risk management plan has been developed to ensure that Episalvan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Episalvan, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Episalvan

The European Commission granted a marketing authorisation valid throughout the European Union for Episalvan on 14 January 2016.

For more information about treatment with Episalvan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Episalvan : EPAR - Summary for the public BG = bălgarski 05/02/2016  
Episalvan : EPAR - Summary for the public ES = español 05/02/2016  
Episalvan : EPAR - Summary for the public CS = čeština 05/02/2016  
Episalvan : EPAR - Summary for the public DA = dansk 05/02/2016  
Episalvan : EPAR - Summary for the public DE = Deutsch 05/02/2016  
Episalvan : EPAR - Summary for the public ET = eesti keel 05/02/2016  
Episalvan : EPAR - Summary for the public EL = elliniká 05/02/2016  
Episalvan : EPAR - Summary for the public EN = English 05/02/2016  
Episalvan : EPAR - Summary for the public FR = français 05/02/2016  
Episalvan : EPAR - Summary for the public IT = italiano 05/02/2016  
Episalvan : EPAR - Summary for the public LV = latviešu valoda 05/02/2016  
Episalvan : EPAR - Summary for the public LT = lietuvių kalba 05/02/2016  
Episalvan : EPAR - Summary for the public HU = magyar 05/02/2016  
Episalvan : EPAR - Summary for the public MT = Malti 05/02/2016  
Episalvan : EPAR - Summary for the public NL = Nederlands 05/02/2016  
Episalvan : EPAR - Summary for the public PL = polski 05/02/2016  
Episalvan : EPAR - Summary for the public PT = português 05/02/2016  
Episalvan : EPAR - Summary for the public RO = română 05/02/2016  
Episalvan : EPAR - Summary for the public SK = slovenčina 05/02/2016  
Episalvan : EPAR - Summary for the public SL = slovenščina 05/02/2016  
Episalvan : EPAR - Summary for the public FI = suomi 05/02/2016  
Episalvan : EPAR - Summary for the public SV = svenska 05/02/2016  
Episalvan : EPAR - Summary for the public HR = Hrvatski 05/02/2016  
Name Language First published Last updated
Episalvan : EPAR - Risk-management-plan summary (English only) 05/02/2016  

This EPAR was last updated on 05/02/2016 .

Authorisation details

Product details

Product details for Episalvan
NameEpisalvan
Agency product numberEMEA/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 Wound HealingWounds and Injuries
Anatomical therapeutic chemical (ATC) code D03
Additional monitoring

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

Publication details

Publication details for Episalvan
Marketing-authorisation holder

Birken AG

Revision0
Date of issue of marketing authorisation valid throughout the European Union14/01/2016

Contact address:

Birken AG
Streiflingsweg 11 
75223 Niefern-Oschelbronn
Germany

Product information

Product information

14/01/2016  Episalvan -EMEA/H/C/003938

Name Language First published Last updated
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  
Episalvan : EPAR - Product Information EN = English 05/02/2016  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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.


Name Language First published Last updated
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  
Episalvan : EPAR - All Authorised presentations EN = English 05/02/2016  

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Episalvan : EPAR - Public assessment report EN = English 05/02/2016  
CHMP summary of opinion for Episalvan EN = English 20/11/2015  

Authorised

This medicine is approved for use in the European Union