CMDh News – March 2015
CMDh agreed by consensus new PRAC recommendations for hydroxyzine-containing medicines
At its March 2015 meeting, the Co-ordination Group for Mutual Recognition and Decentralised Procedure (CMDh) has agreed by consensus the PRAC recommendations to include new information in the summary of product characteristics and package leaflet for hydroxyzine-containing medicines due to the risk of effects on heart rhythm.
There are no authorised medicines with this active substance in the Republic of Croatia. More information is accessible on the European Medicines Agency’s (EMA) webpages, or here.
Deletion of interaction between broad spectrum antibiotics and combined oral contraceptives (COC)
In the WHO’s Medical Eligibility Criteria for Contraceptive use (MEC) editions 2004 and 2009, the WHO concludes that there is "intermediate level” evidence that the contraceptive effectiveness of combined oral contraceptives is not affected by co-administration of most broad spectrum antibiotics. This conclusion is based on the WHO assessment report "Hormonal contraceptive use in women taking antibiotics”. The interaction has been deleted in some products as an outcome of the worksharing procedure NL/H/xxxx/WS/063. Based on this scientific assessment, the CMDh recommends deleting the interaction in all concerned products and has therefore agreed to make the assessment report of the procedure NL/H/xxxx/WS/063 available on the CMDh website, together with a cover note and a list of ATC codes for which the change applies.
The change should be implemented within 1 year following publication of the PAR, either in the course of another regulatory procedure, e.g. renewal or as part of a (grouped) variation application of type IB or type II of the "C” category of the Classification Guideline affecting the product information, or through a separate variation under C.I.z (Type IAIN if no further assessment needed, type IB if minor assessment needed). The related documents will be published under "Advice from CMDh”, or here.
EU Work-sharing Article 45 & 46 of the Paediatric Regulation - Public Assessment Reports
The CMDh has agreed public assessment reports for paediatric studies submitted in accordance with Article 45 of the Paediatric Regulation. The paediatric public assessment reports for famotidine (in combinations), levocabastine and pravastatin sodium, including recommendations for the text to be included in the SmPC and package leaflet, will be published on the CMDh website, under "Paediatric Regulation, Assessment reports”, or here.
Marketing authorisation holders of medicinal products with the same active substances and pharmaceutical forms are requested to include this information in their SmPCs and package leaflets within 90 days of publication of the public assessment reports, in accordance with the Best Practice Guide - Article 45, EU Work-sharing procedure.
The CMDh has also agreed on a public assessment report for paediatric studies submitted in accordance with Article 46 of the Paediatric Regulation for Seretide Accuhaler/Diskus (salmeterol/fluticasone propionate).
Revision of CMDh position paper on the use of Quick Response (QR) codes to provide information about the medicinal product
The CMDh has revised the above mentioned document to clarify that for MRP/DCP products the URL can be included in the packaging without the corresponding QR code. The same conditions as for the QR code apply to the URL alone, as detailed in the document.
The CMDh position paper has been published on the CMDh website under "Procedural guidance, General Info”, or here.
News from the CMDh meetins are accessible on the DMDh/HMA webpages, or here.