Evicel
human fibrinogen / human thrombin
Table of contents
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.
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Evicel : EPAR - Summary for the public (PDF/78.55 KB)
First published: 09/12/2008
Last updated: 17/09/2013 -
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Evicel : EPAR - Risk-management-plan summary (PDF/117.8 KB)
First published: 12/06/2020
Last updated: 22/06/2020
Authorisation details
Product details | |
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Name |
Evicel
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Agency product number |
EMEA/H/C/000898
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Hemostasis, Surgical
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Anatomical therapeutic chemical (ATC) code |
B02BC
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Publication details | |
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Marketing-authorisation holder |
Omrix Biopharmaceuticals N. V.
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Revision |
16
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Date of issue of marketing authorisation valid throughout the European Union |
05/10/2008
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Contact address |
Product information
28/10/2020 Evicel - EMEA/H/C/000898 - IA/0085
Contents
- 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.
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.