Dexrazoxane

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

Overview

The European Medicines Agency has completed a review of the safety and effectiveness of dexrazoxane. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that dexrazoxane should not be used in children and adolescents. The Committee has also made recommendations for changes to the summaries of product characteristics (SmPCs) for dexrazoxane-containing medicines.

Key facts

Approved name
Dexrazoxane
International non-proprietary name (INN) or common name
dexrazoxane
Associated names
  • Cardioxane
  • Cyrdanax
  • Dexrazoxane Cyathus
  • Enaxozar
  • Procard
Reference number
EMEA/H/A-31/1275
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
23/06/2011
EC decision date
13/09/2011

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

How useful was this page?

Add your rating