human fibrinogen / human thrombin
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.
Evicel : EPAR - Summary for the public (PDF/78.55 KB)
First published: 09/12/2008
Last updated: 17/09/2013
Evicel : EPAR - Risk-management-plan summary (PDF/117.8 KB)
First published: 12/06/2020
Last updated: 22/06/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Omrix Biopharmaceuticals N. V.
|Date of issue of marketing authorisation valid throughout the European Union||
28/10/2020 Evicel - EMEA/H/C/000898 - IA/0085
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.