Cardioxane
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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
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About this medicine
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|---|---|
| Approved name |
Cardioxane
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| International non-proprietary name (INN) or common name |
dexrazoxane
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About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-13/1453
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| 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. |
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
19/07/2017
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| EC decision date |
19/07/2017
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All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Cardioxane Article 13 referral - CHMP assessment report (PDF/184.43 KB)
First published: 26/07/2017
Last updated: 26/07/2017
Cardioxane Article 13 referral - Annex I (PDF/35.55 KB)
First published: 26/07/2017
Last updated: 26/07/2017
Cardioxane Article 13 referral - Annex II (PDF/37.02 KB)
First published: 26/07/2017
Last updated: 26/07/2017
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.