Overview

The marketing authorisation for Evarrest has been withdrawn at the request of the marketing-authorisation holder.

Evarrest : EPAR - Summary for the public

Reference Number: EMA/413962/2013

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italiano (IT) (514.66 KB - PDF)

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latviešu valoda (LV) (593.61 KB - PDF)

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Nederlands (NL) (514.67 KB - PDF)

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polski (PL) (576.8 KB - PDF)

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português (PT) (536.9 KB - PDF)

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română (RO) (1020.06 KB - PDF)

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slovenčina (SK) (100.5 KB - PDF)

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slovenščina (SL) (567.85 KB - PDF)

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Suomi (FI) (513.9 KB - PDF)

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svenska (SV) (514.56 KB - PDF)

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Product information

Evarrest : EPAR - Product Information

English (EN) (861.4 KB - PDF)

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български (BG) (1.55 MB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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español (ES) (896.44 KB - PDF)

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čeština (CS) (1.51 MB - PDF)

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dansk (DA) (813.54 KB - PDF)

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Deutsch (DE) (845.01 KB - PDF)

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eesti keel (ET) (787.41 KB - PDF)

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ελληνικά (EL) (1.55 MB - PDF)

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français (FR) (818.58 KB - PDF)

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hrvatski (HR) (898.08 KB - PDF)

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íslenska (IS) (877.78 KB - PDF)

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italiano (IT) (816.34 KB - PDF)

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latviešu valoda (LV) (1.31 MB - PDF)

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lietuvių kalba (LT) (910.1 KB - PDF)

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magyar (HU) (1.15 MB - PDF)

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Malti (MT) (1.31 MB - PDF)

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Nederlands (NL) (827.81 KB - PDF)

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norsk (NO) (860 KB - PDF)

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polski (PL) (1.32 MB - PDF)

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português (PT) (818.67 KB - PDF)

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română (RO) (934.43 KB - PDF)

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slovenčina (SK) (1.32 MB - PDF)

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slovenščina (SL) (1.25 MB - PDF)

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Suomi (FI) (923.42 KB - PDF)

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svenska (SV) (864.7 KB - PDF)

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Latest procedure affecting product information: II/0027/G

15/11/2017

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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).

Evarrest : EPAR - All Authorised presentations

English (EN) (456.24 KB - PDF)

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български (BG) (496.48 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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español (ES) (460.12 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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čeština (CS) (486.03 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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dansk (DA) (460.06 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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Deutsch (DE) (459.93 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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eesti keel (ET) (459.94 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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ελληνικά (EL) (496.65 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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français (FR) (459.86 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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hrvatski (HR) (472.28 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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íslenska (IS) (460 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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italiano (IT) (459.91 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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latviešu valoda (LV) (489.48 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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lietuvių kalba (LT) (474.86 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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magyar (HU) (484.42 KB - PDF)

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Malti (MT) (490.05 KB - PDF)

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Nederlands (NL) (459.69 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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norsk (NO) (459.61 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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polski (PL) (489.07 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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português (PT) (459.81 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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română (RO) (930.92 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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slovenčina (SK) (29.59 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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slovenščina (SL) (483.95 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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Suomi (FI) (460.2 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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svenska (SV) (459.88 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
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Product details

Name of medicine
Evarrest
Active substance
  • human fibrinogen
  • human thrombin
International non-proprietary name (INN) or common name
  • human fibrinogen
  • human thrombin
Therapeutic area (MeSH)
Hemostasis
Anatomical therapeutic chemical (ATC) code
B02BC30

Pharmacotherapeutic group

Local hemostatics

Therapeutic indication

Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1):

- for improvement of haemostasis.

Authorisation details

EMA product number
EMEA/H/C/002515
Marketing authorisation holder
Omrix Biopharmaceuticals N. V.

Leonardo Da Vinci Laan 15
1831 Diegem
Belgium

Marketing authorisation issued
25/09/2013
Revision
4

Assessment history

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

English (EN) (551.25 KB - PDF)

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Evarrest : EPAR - Public assessment report

AdoptedReference Number: EMA/464286/2013

English (EN) (2.05 MB - PDF)

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CHMP summary of positive opinion for Evarrest

AdoptedReference Number: EMA/CHMP/385035/2013

English (EN) (504.42 KB - PDF)

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More information on Evarrest

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

Reference Number: EMA/24202/2018

English (EN) (59.2 KB - PDF)

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