Overview

The marketing authorisation for Evarrest has been withdrawn at the request of the marketing-authorisation holder.

Evarrest : EPAR - Summary for the public

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Product information

Evarrest : EPAR - Product Information

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Suomi (FI) (923.42 KB - PDF)
svenska (SV) (864.7 KB - PDF)

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.
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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

български (BG) (496.48 KB - PDF)
español (ES) (460.12 KB - PDF)
čeština (CS) (486.03 KB - PDF)
dansk (DA) (460.06 KB - PDF)
Deutsch (DE) (459.93 KB - PDF)
eesti keel (ET) (459.94 KB - PDF)
ελληνικά (EL) (496.65 KB - PDF)
français (FR) (459.86 KB - PDF)
hrvatski (HR) (472.28 KB - PDF)
íslenska (IS) (460 KB - PDF)
italiano (IT) (459.91 KB - PDF)
latviešu valoda (LV) (489.48 KB - PDF)
lietuvių kalba (LT) (474.86 KB - PDF)
magyar (HU) (484.42 KB - PDF)
Malti (MT) (490.05 KB - PDF)
Nederlands (NL) (459.69 KB - PDF)
norsk (NO) (459.61 KB - PDF)
polski (PL) (489.07 KB - PDF)
português (PT) (459.81 KB - PDF)
română (RO) (930.92 KB - PDF)
slovenčina (SK) (29.59 KB - PDF)
slovenščina (SL) (483.95 KB - PDF)
Suomi (FI) (460.2 KB - PDF)
svenska (SV) (459.88 KB - PDF)

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

Evarrest : EPAR - Public assessment report

CHMP summary of positive opinion for Evarrest

Topics

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