Evarrest

RSS
Withdrawn

This medicine's authorisation has been withdrawn

human fibrinogen / human thrombin
MedicineHumanWithdrawn
  • 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Assessment Report (EPAR) for Evarrest is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.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)

First published: Last updated:
View

български (BG) (597.14 KB - PDF)

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

español (ES) (515.07 KB - PDF)

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

čeština (CS) (578.52 KB - PDF)

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

dansk (DA) (518.89 KB - PDF)

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

Deutsch (DE) (516.28 KB - PDF)

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

eesti keel (ET) (518.26 KB - PDF)

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

ελληνικά (EL) (600.8 KB - PDF)

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

français (FR) (518 KB - PDF)

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

hrvatski (HR) (535.13 KB - PDF)

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

italiano (IT) (514.66 KB - PDF)

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

latviešu valoda (LV) (593.61 KB - PDF)

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

lietuvių kalba (LT) (538.4 KB - PDF)

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

magyar (HU) (571.9 KB - PDF)

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

Malti (MT) (577.35 KB - PDF)

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

Nederlands (NL) (514.67 KB - PDF)

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

polski (PL) (576.8 KB - PDF)

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

português (PT) (536.9 KB - PDF)

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

română (RO) (1020.06 KB - PDF)

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

slovenčina (SK) (100.5 KB - PDF)

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

slovenščina (SL) (567.85 KB - PDF)

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

Suomi (FI) (513.9 KB - PDF)

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

svenska (SV) (514.56 KB - PDF)

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

Product information

Evarrest : EPAR - Product Information

English (EN) (861.4 KB - PDF)

First published: Last updated:
View

български (BG) (1.55 MB - PDF)

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

español (ES) (896.44 KB - PDF)

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

čeština (CS) (1.51 MB - PDF)

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

dansk (DA) (813.54 KB - PDF)

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

Deutsch (DE) (845.01 KB - PDF)

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

eesti keel (ET) (787.41 KB - PDF)

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

ελληνικά (EL) (1.55 MB - PDF)

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

français (FR) (818.58 KB - PDF)

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

hrvatski (HR) (898.08 KB - PDF)

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

íslenska (IS) (877.78 KB - PDF)

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

italiano (IT) (816.34 KB - PDF)

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

latviešu valoda (LV) (1.31 MB - PDF)

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

lietuvių kalba (LT) (910.1 KB - PDF)

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

magyar (HU) (1.15 MB - PDF)

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

Malti (MT) (1.31 MB - PDF)

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

Nederlands (NL) (827.81 KB - PDF)

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

norsk (NO) (860 KB - PDF)

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

polski (PL) (1.32 MB - PDF)

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

português (PT) (818.67 KB - PDF)

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

română (RO) (934.43 KB - PDF)

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

slovenčina (SK) (1.32 MB - PDF)

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

slovenščina (SL) (1.25 MB - PDF)

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

Suomi (FI) (923.42 KB - PDF)

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

svenska (SV) (864.7 KB - PDF)

First published: 07/10/2013Last updated: 03/04/2018
View
Latest procedure affecting product information: II/0027/G
15/11/2017
icon globe

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:
View

български (BG) (496.48 KB - PDF)

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

español (ES) (460.12 KB - PDF)

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

čeština (CS) (486.03 KB - PDF)

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

dansk (DA) (460.06 KB - PDF)

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

Deutsch (DE) (459.93 KB - PDF)

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

eesti keel (ET) (459.94 KB - PDF)

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

ελληνικά (EL) (496.65 KB - PDF)

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

français (FR) (459.86 KB - PDF)

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

hrvatski (HR) (472.28 KB - PDF)

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

íslenska (IS) (460 KB - PDF)

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

italiano (IT) (459.91 KB - PDF)

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

latviešu valoda (LV) (489.48 KB - PDF)

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

lietuvių kalba (LT) (474.86 KB - PDF)

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

magyar (HU) (484.42 KB - PDF)

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

Malti (MT) (490.05 KB - PDF)

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

Nederlands (NL) (459.69 KB - PDF)

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

norsk (NO) (459.61 KB - PDF)

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

polski (PL) (489.07 KB - PDF)

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

português (PT) (459.81 KB - PDF)

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

română (RO) (930.92 KB - PDF)

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

slovenčina (SK) (29.59 KB - PDF)

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

slovenščina (SL) (483.95 KB - PDF)

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

Suomi (FI) (460.2 KB - PDF)

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

svenska (SV) (459.88 KB - PDF)

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

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:
View

Evarrest : EPAR - Public assessment report

AdoptedReference Number: EMA/464286/2013

English (EN) (2.05 MB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Evarrest

AdoptedReference Number: EMA/CHMP/385035/2013

English (EN) (504.42 KB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page

Back to top