Evicel

RSS

human fibrinogen / human thrombin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Evicel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evicel.

This EPAR was last updated on 17/11/2020

Authorisation details

Product details
Name
Evicel
Agency product number
EMEA/H/C/000898
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
Publication details
Marketing-authorisation holder
Omrix Biopharmaceuticals N. V.
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
05/10/2008
Contact address
Leonardo Da Vinci Laan15
B-1831 Diegem
Belgium

Product information

28/10/2020 Evicel - EMEA/H/C/000898 - IA/0085

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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