Overview

The marketing authorisation for Episalvan has been withdrawn at the request of the marketing-authorisation holder.

Episalvan : EPAR - Summary for the public

Reference Number: EMA/785623/2015

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български (BG) (296.74 KB - PDF)

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čeština (CS) (287.15 KB - PDF)

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dansk (DA) (244.24 KB - PDF)

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Deutsch (DE) (250.92 KB - PDF)

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eesti keel (ET) (242.95 KB - PDF)

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ελληνικά (EL) (317.24 KB - PDF)

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français (FR) (250.22 KB - PDF)

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hrvatski (HR) (267.8 KB - PDF)

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italiano (IT) (244.82 KB - PDF)

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latviešu valoda (LV) (285 KB - PDF)

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lietuvių kalba (LT) (270.73 KB - PDF)

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magyar (HU) (291.39 KB - PDF)

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Malti (MT) (289.33 KB - PDF)

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Nederlands (NL) (248.9 KB - PDF)

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polski (PL) (287.6 KB - PDF)

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português (PT) (246.11 KB - PDF)

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română (RO) (269.5 KB - PDF)

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slovenčina (SK) (287.29 KB - PDF)

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slovenščina (SL) (279.06 KB - PDF)

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Suomi (FI) (244.39 KB - PDF)

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svenska (SV) (244.65 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Episalvan : EPAR - Risk-management-plan summary

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Product information

Episalvan : EPAR - Product Information

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български (BG) (808.66 KB - PDF)

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español (ES) (404.89 KB - PDF)

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čeština (CS) (640.06 KB - PDF)

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dansk (DA) (413.47 KB - PDF)

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Deutsch (DE) (432.51 KB - PDF)

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eesti keel (ET) (398.81 KB - PDF)

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ελληνικά (EL) (843.43 KB - PDF)

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français (FR) (426.81 KB - PDF)

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hrvatski (HR) (494.83 KB - PDF)

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íslenska (IS) (412.08 KB - PDF)

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italiano (IT) (413.48 KB - PDF)

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latviešu valoda (LV) (676.12 KB - PDF)

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lietuvių kalba (LT) (503.12 KB - PDF)

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magyar (HU) (653.64 KB - PDF)

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Malti (MT) (668.13 KB - PDF)

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Nederlands (NL) (420.11 KB - PDF)

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norsk (NO) (409.62 KB - PDF)

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polski (PL) (672.77 KB - PDF)

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português (PT) (413.49 KB - PDF)

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română (RO) (513.12 KB - PDF)

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slovenčina (SK) (659.65 KB - PDF)

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slovenščina (SL) (633.51 KB - PDF)

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Suomi (FI) (464.57 KB - PDF)

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svenska (SV) (412.87 KB - PDF)

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07/06/2022

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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).

Episalvan : EPAR - All Authorised presentations

English (EN) (224.16 KB - PDF)

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български (BG) (213.15 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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español (ES) (179.64 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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čeština (CS) (206.85 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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dansk (DA) (178.94 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Deutsch (DE) (179.35 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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eesti keel (ET) (179.37 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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ελληνικά (EL) (214.3 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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français (FR) (178.46 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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hrvatski (HR) (192.58 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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íslenska (IS) (184.82 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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italiano (IT) (180 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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latviešu valoda (LV) (238.07 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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lietuvių kalba (LT) (197.73 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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magyar (HU) (204.56 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Malti (MT) (207.5 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Nederlands (NL) (179.14 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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norsk (NO) (184.87 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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polski (PL) (206.18 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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português (PT) (179.38 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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română (RO) (196.46 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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slovenčina (SK) (206.29 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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slovenščina (SL) (200.6 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Suomi (FI) (180.06 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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svenska (SV) (180.74 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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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 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.

Authorisation details

EMA product number
EMEA/H/C/003938
Marketing authorisation holder
Amryt AG

Streiflingsweg 11
75223 Niefern-Oschelbronn
Germany

Opinion adopted
19/11/2015
Marketing authorisation issued
14/01/2016
Revision
7

Assessment history

Episalvan : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (327.1 KB - PDF)

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Episalvan : EPAR - Public assessment report

AdoptedReference Number: EMA/833320/2015

English (EN) (5.7 MB - PDF)

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CHMP summary of opinion for Episalvan

AdoptedReference Number: EMA/765144/2015

English (EN) (233.95 KB - PDF)

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More information on Episalvan

Public statement on Episalvan: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/366849/2022

English (EN) (101.94 KB - PDF)

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