- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
The European Medicines Agency has completed an arbitration procedure for Extraneal 7.5% solution for peritoneal dialysis. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the change to the marketing authorisation for Extraneal to include a peptidoglycan test can be granted, and that the use of the active substance icodextrin sourced from one of the currently approved manufacturers should cease.
The review was carried out under an 'Article 6(12)' referral1
The European Commission issued a decision on 10 January 2010.
1 Article 6(12) of Regulation (EC) 1084/2003 as amended, referral on a variation to a marketing authorisation
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
Article 6(12) referrals (prior to January 2010)
This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.
European Commission final decision
Key dates and outcomes
|CHMP opinion date||
|EC decision date||
Questions and answers on the referral for Extraneal icodextrin 7.5% solution for peritoneal dialysis (PDF/32.74 KB)Adopted
First published: 27/10/2009
Last updated: 10/02/2010
Extraneal - Article 6(12) referral - Annex I, II, III, IV (PDF/35.23 KB)Adopted
First published: 10/02/2010
Last updated: 10/02/2010
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.