Cardioxane

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

Overview

Questions and answers on Cardioxane (dexrazoxane, powder for solution for injection, 500 mg)

Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008

On 18 May 2017, the European Medicines Agency completed an arbitration procedure for Cardioxane (dexrazoxane powder for solution for injection). The Agency had been asked to arbitrate on the removal of the contraindication for children and adolescents treated with high cumulative doses of cancer medicines called anthracyclines. Its Committee for Medicinal Products for Human Use (CHMP) concluded that such a removal is acceptable. The contraindication should however remain in children and adolescents who are given lower cumulative doses of anthracyclines.

Key facts

Approved name
Cardioxane
International non-proprietary name (INN) or common name
dexrazoxane
Reference number
EMEA/H/A-13/1453
Type
Article 13 referrals

This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
19/07/2017
EC decision date
19/07/2017

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:

News

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