Evarrest

Withdrawn

This medicine's authorisation has been withdrawn

human fibrinogen / human thrombin

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Assessment Report (EPAR) for Evarrest is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.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

Product information

Evarrest : EPAR - Product Information

Evarrest : EPAR - All Authorised presentations

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

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Evarrest : EPAR - Public assessment report

Adopted Reference Number: EMA/464286/2013

CHMP summary of positive opinion for Evarrest

Adopted Reference Number: EMA/CHMP/385035/2013