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/194.86 KB)
First published: 12/06/2020
Last updated: 11/05/2023
|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||
Leonardo Da Vinci Laan15
16/03/2023 Evicel - EMEA/H/C/000898 - II/0099
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
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.
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.