CMDh News – May 2015


CMDh agreed by consensus the recommendations for ibuprofen- and dexibuprofen-containing medicines

At its meeting held in May 2015, having considered the PRAC assessment report and recommendation the Co-ordination Group for Mutual Recognition and Decentralised Procedure, agreed by consensus that the marketing authorisations for ibuprofen and dexibuprofen-containing medicines should be updated to minimise the small increased risk of cardiovascular problems, such as heart attacks and strokes.

Further information on the agreed recommendations has been published on the HALMED webpages, or here. HALMED will publish instructions and deadlines for reporting variations in documentation as outcome of this referral, after the translations that should be included in the product information have been published.

CMDh agreed by consensus the PRAC recommendation following PSUSA procedure for only nationally authorised products

The CMDh, having considered the PSUR on the basis of the PRAC recommendation and the PRAC assessment report, agreed by consensus on the variation of the marketing authorisations of medicinal products containing the combination atenolol/chlortalidone. The CMDh strongly recommends to marketing authorisation holders of medicinal products containing atenolol as a single active substance or atenolol in other combinations to take into account the outcome of the procedure and to update the product information by the appropriate variation. Further information regarding the above-mentioned PSUSA procedure, including information on the implementation, will be published on the EMA website.

Implementation of the referral procedure pursuant to the Article 31 of Directive 2001/83/EC of the European Parliament and Council on polymyxin-containing medicines

The CHMP reviewed the safety and effectiveness of products containing colistin or colistimethate sodium (known as polymyxins) in the framework of a procedure under Article 31 of Directive 2001/83/EC and recommended changes to their product information. The CMDh, having considered the CHMP opinion, agreed during its May 2015 meeting that additional clarifications and guidance were needed to support the implementation of the outcome of this procedure.

The CHMP identified a clinical need to provide information on intrathecal & intraventricular administration of polymyxin-based products and considered that this additional information could be added to the product information of polymyxin-based products authorised for parenteral use (injection and infusion), when appropriate.

Addition of the intrathecal & intraventricular routes of administration is expected to be suitable for the currently approved products for parenteral administration, provided that the pharmaceutical characteristics (e.g. composition, pH, tonicity, concentration, microbiological quality, bacterial endotoxins limit) of the product are appropriate for these routes of administration. The suitability of the product composition, its method of reconstitution, administration volume and compliance with the European Pharmacopoeia requirements for bacterial endotoxin should be confirmed by the MAH.

If the pharmaceutical characteristics of the parenteral product are not suitable for these routes of administration (e.g. inappropriate bacterial endotoxins limit), an appropriate quality variation should be submitted. Further information is available on the CMDh/HMA website, or here.

News from the CMDh meeting are available on the CMDh/HMA website, or here.