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

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

On 15 November 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Evicel and Quixil given by spray application, following cases of gas embolisms reported with these medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines given by spray application continue to outweigh their risks, but that appropriate measures have to be put in place to minimise the risk of gas embolism.

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
Quixil
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
15/11/2012
EC decision date
13/02/2013

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:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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