Fibrinogen-containing solutions for sealant authorised for administration by spray application

Current status:
European Commission final decision

Overview

On 13 December 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names), following concerns over the risk of gas embolism when these medicines are given by spray application. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines continue to outweigh their risks, but that appropriate measures have to be put in place to optimise the safe use of these medicines when they are applied as a spray during surgery.

Key facts

Approved name
Fibrinogen-containing solutions for sealant authorised for administration by spray application
International non-proprietary name (INN) or common name
Fibrin
Associated names
  • Tisseel
  • Tissucol
  • Artiss
  • Beriplast P
Class
Fibrin sealants
Reference number
EMEA/H/A-31/1337
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
13/12/2012
EC decision date
15/03/2013

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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