Evarrest

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Withdrawn

This medicine's authorisation has been withdrawn

human fibrinogen / human thrombin
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 15 November 2017, the European Commission withdrew the marketing authorisation for Evarrest (human fibrinogen / human thrombin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Omrix Biopharmaceuticals N. V., which notified the European Commission of its decision to permanently discontinue the marketing of the product in the EU for commercial reasons. 

Evarrest was granted marketing authorisation in the EU on 25 September 2013 for the treatment of haemostasis and as an adjunct to haemostasis in bleeding.

The European Public Assessment Report (EPAR) for Evarrest is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Evarrest : EPAR - Summary for the public

Reference Number: EMA/413962/2013

English (EN) (514.84 KB - PDF)

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български (BG) (597.14 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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español (ES) (515.07 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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čeština (CS) (578.52 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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dansk (DA) (518.89 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Deutsch (DE) (516.28 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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eesti keel (ET) (518.26 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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ελληνικά (EL) (600.8 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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français (FR) (518 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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hrvatski (HR) (535.13 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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italiano (IT) (514.66 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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latviešu valoda (LV) (593.61 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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lietuvių kalba (LT) (538.4 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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magyar (HU) (571.9 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Malti (MT) (577.35 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Nederlands (NL) (514.67 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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polski (PL) (576.8 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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português (PT) (536.9 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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română (RO) (1020.06 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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slovenčina (SK) (100.5 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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slovenščina (SL) (567.85 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Suomi (FI) (513.9 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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svenska (SV) (514.56 KB - PDF)

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

Evarrest : EPAR - Product Information

English (EN) (861.4 KB - PDF)

First published: Last updated:
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български (BG) (1.55 MB - PDF)

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

First published: 07/10/2013 Last updated: 03/04/2018
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čeština (CS) (1.51 MB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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dansk (DA) (813.54 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Deutsch (DE) (845.01 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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eesti keel (ET) (787.41 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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ελληνικά (EL) (1.55 MB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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français (FR) (818.58 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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hrvatski (HR) (898.08 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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íslenska (IS) (877.78 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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italiano (IT) (816.34 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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latviešu valoda (LV) (1.31 MB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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lietuvių kalba (LT) (910.1 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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magyar (HU) (1.15 MB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Malti (MT) (1.31 MB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Nederlands (NL) (827.81 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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norsk (NO) (860 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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polski (PL) (1.32 MB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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português (PT) (818.67 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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română (RO) (934.43 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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slovenčina (SK) (1.32 MB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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slovenščina (SL) (1.25 MB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Suomi (FI) (923.42 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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svenska (SV) (864.7 KB - PDF)

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

First published: Last updated:
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български (BG) (496.48 KB - PDF)

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

español (ES) (460.12 KB - PDF)

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

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

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

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

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

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

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

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

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

italiano (IT) (459.91 KB - PDF)

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

latviešu valoda (LV) (489.48 KB - PDF)

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

lietuvių kalba (LT) (474.86 KB - PDF)

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

magyar (HU) (484.42 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Malti (MT) (490.05 KB - PDF)

First published: 07/10/2013 Last updated: 03/04/2018
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Nederlands (NL) (459.69 KB - PDF)

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

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

polski (PL) (489.07 KB - PDF)

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

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

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

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

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

Suomi (FI) (460.2 KB - PDF)

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

First published: 07/10/2013 Last 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
Withdrawal of marketing authorisation
15/11/2017
Revision
4

Assessment history

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

English (EN) (551.25 KB - PDF)

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

Adopted Reference Number: EMA/464286/2013

English (EN) (2.05 MB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Evarrest

Adopted Reference Number: EMA/CHMP/385035/2013

English (EN) (504.42 KB - PDF)

First published: Last updated:
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