Evicel

Withdrawn

This medicine's authorisation has been withdrawn

human fibrinogen / human thrombin

Overview

On 5 July 2024, the European Commission withdrew the marketing authorisation for Evicel (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 for commercial reasons. 

Evicel was granted marketing authorisation in the EU on 6 October 2008 for supportive treatment in surgery, improvement of haemostasis and suture support for haemostasis in vascular surgery. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2013. 

Evicel is identical to TachoSil and VeraSeal, which are authorised in the EU for supportive treatment in surgery, improvement of haemostasis and suture support for haemostasis in vascular surgery. 

The European Public Assessment Report (EPAR) for Evicel is updated to indicate that the marketing authorisation is no longer valid.

Evicel : EPAR - Summary for the public

Evicel : EPAR - Risk-management-plan summary

Product information

Evicel : EPAR - Product Information

Evicel : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Evicel
• Active substance:
  • human fibrinogen
  • human thrombin
• International non-proprietary name (INN) or common name:
  • human fibrinogen
  • human thrombin
• Therapeutic area (MeSH):
  Hemostasis, Surgical
• Anatomical therapeutic chemical (ATC) code:
  B02BC

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.

Evicel is also indicated as suture support for haemostasis in vascular surgery.

Authorisation details

• EMA product number:
  EMEA/H/C/000898
• Marketing authorisation holder:
  Omrix Biopharmaceuticals N. V.

  Leonardo Da Vinci Laan15; B-1831 Diegem; Belgium

• Opinion adopted:
  24/07/2008
• Marketing authorisation issued:
  05/10/2008
• Revision:
  18

Assessment history

Changes since initial authorisation of medicine

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

Evicel-H-C-898-P46-0030 : EPAR - Assessment report

Adopted Reference Number: EMA/CHMP/577885/2022

Evicel-H-C-898-II-0021 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/474697/2013

CHMP post-authorisation summary of positive opinion for Evicel

Adopted Reference Number: EMA/CHMP/393917/2013

Evicel-H-C-898-A20-0018 : EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/66677/2013

Initial marketing authorisation documents

Evicel : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Evicel

Reference Number: EMEA/CHMP/399406/2008