Evarrest
human fibrinogen / human thrombin
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Evarrest has been withdrawn at the request of the marketing-authorisation holder.
This EPAR was last updated on 03/04/2018
Authorisation details
| Product details | |
|---|---|
| Name |
Evarrest
|
| Agency product number |
EMEA/H/C/002515
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
human fibrinogen / human thrombin
|
| Therapeutic area (MeSH) |
Hemostasis
|
| Anatomical therapeutic chemical (ATC) code |
B02BC30
|
| Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Omrix Biopharmaceuticals N. V.
|
| Revision |
4
|
| Date of issue of marketing authorisation valid throughout the European Union |
25/09/2013
|
| Contact address | |
Product information
15/11/2017 Evarrest - EMEA/H/C/002515 - II/0027/G
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
Haemostatic combinations
Therapeutic indication
Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1):
- for improvement of haemostasis.