Episalvan

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Withdrawn

This medicine's authorisation has been withdrawn

birch bark extract
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 7 June 2022, the European Commission withdrew the marketing authorisation for Episalvan (birch bark extract) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amryt GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Episalvan was granted marketing authorisation in the EU on 14 January 2016 for the treatment of partial thickness wounds in adults. 

The European Public Assessment Report (EPAR) for Episalvan is updated to indicate that the marketing authorisation is no longer valid.

Episalvan : EPAR - Summary for the public

Reference Number: EMA/785623/2015

English (EN) (247.82 KB - PDF)

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български (BG) (296.74 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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español (ES) (245.78 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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čeština (CS) (287.15 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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dansk (DA) (244.24 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Deutsch (DE) (250.92 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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eesti keel (ET) (242.95 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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ελληνικά (EL) (317.24 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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français (FR) (250.22 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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hrvatski (HR) (267.8 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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italiano (IT) (244.82 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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latviešu valoda (LV) (285 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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lietuvių kalba (LT) (270.73 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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magyar (HU) (291.39 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Malti (MT) (289.33 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Nederlands (NL) (248.9 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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polski (PL) (287.6 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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português (PT) (246.11 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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română (RO) (269.5 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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slovenčina (SK) (287.29 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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slovenščina (SL) (279.06 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Suomi (FI) (244.39 KB - PDF)

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

English (EN) (225.92 KB - PDF)

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Product information

Episalvan : EPAR - Product Information

English (EN) (417.18 KB - PDF)

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български (BG) (808.66 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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español (ES) (404.89 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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čeština (CS) (640.06 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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dansk (DA) (413.47 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Deutsch (DE) (432.51 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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eesti keel (ET) (398.81 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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ελληνικά (EL) (843.43 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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français (FR) (426.81 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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hrvatski (HR) (494.83 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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íslenska (IS) (412.08 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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italiano (IT) (413.48 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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latviešu valoda (LV) (676.12 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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lietuvių kalba (LT) (503.12 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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magyar (HU) (653.64 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Malti (MT) (668.13 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Nederlands (NL) (420.11 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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norsk (NO) (409.62 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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polski (PL) (672.77 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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português (PT) (413.49 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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română (RO) (513.12 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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slovenčina (SK) (659.65 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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slovenščina (SL) (633.51 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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Suomi (FI) (464.57 KB - PDF)

First published: 05/02/2016Last updated: 15/07/2022
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svenska (SV) (412.87 KB - PDF)

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

First published: Last updated:
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български (BG) (213.15 KB - PDF)

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

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
View

hrvatski (HR) (192.58 KB - PDF)

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

íslenska (IS) (184.82 KB - PDF)

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

italiano (IT) (180 KB - PDF)

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

latviešu valoda (LV) (238.07 KB - PDF)

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

lietuvių kalba (LT) (197.73 KB - PDF)

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

magyar (HU) (204.56 KB - PDF)

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

Malti (MT) (207.5 KB - PDF)

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

Nederlands (NL) (179.14 KB - PDF)

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

norsk (NO) (184.87 KB - PDF)

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

polski (PL) (206.18 KB - PDF)

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

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
View

slovenčina (SK) (206.29 KB - PDF)

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

slovenščina (SL) (200.6 KB - PDF)

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

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)

First published: Last updated:
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Episalvan : EPAR - Public assessment report

AdoptedReference Number: EMA/833320/2015

English (EN) (5.7 MB - PDF)

First published: Last updated:
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CHMP summary of opinion for Episalvan

AdoptedReference Number: EMA/765144/2015

English (EN) (233.95 KB - PDF)

First published: Last updated:
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