VeraSeal

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 VeraSeal. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use VeraSeal.

For practical information about using VeraSeal, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 17/01/2018

Authorisation details

Product details
Name
VeraSeal
Agency product number
EMEA/H/C/004446
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
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
Instituto Grifols, S.A.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
10/11/2017
Contact address
Poligono Levante
c/Can Guasc 2
Barcelona 08150
Parets del Valles
Spain

Product information

10/11/2017 VeraSeal - EMEA/H/C/004446 - -

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

Supportive treatment in adults where standard surgical techniques are insufficient:

- for improvement of haemostasis.

- as suture support in vascular surgery

Assessment history

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