Dear Doctor,
CdG Ltd, on behalf of the Marketing Authorisation Holder, is required to send these educational materials (attached) to all doctors specialised in family medicine as part of the dissemination plan agreed upon with the Medicines Authority, which ensures that RMMs of products that fall under this requirement, are duly sent out.
The product concerned is Epilim / Epilim Chrono (valproate) which is subject to aRMMs (additional Risk Minimisation Measures). In line with the updated version of the Risk Management Plan of Valproate products (EMEA-H-N-PSR-J-0043 ) for Epilim and Epilim Chrono, we are proceeding with a further distribution of the educational materials that you can find enclosed herewith.
Kindly note that the documents are aligned in their content to the reference country Ireland and is covering the paternal exposure.
The documents have been approved by the Malta Medicines Authority on 16/07/2024
The full educational material package can be found online at www.medicinesauthority.gov.mt/rmm.
Enter “Epilim” in the search box and find them under PDF format.
Please refer to the most updated SmPC for Epilim / Epilim Chrono in the MMA web site.
Kind regards,
Claire