EMA Picks Valproate For First Public Hearing On Safety Of Marketed Medicines
The European Medicines Agency is re-examining the use of valproate in women to address ongoing safety concerns and will hold its first ever public hearing later this year to listen directly to the experience of EU patients with these medicines.
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The European Medicines Agency is scheduled to adopt final recommendations for improving the safety of the anti-epileptic drug valproate – the subject of the agency’s very first public hearing.
There were passionate testimonies from patients affected by Sanofi’s anti-epileptic drug valproate at the European Medicines Agency's first public hearing on medicines safety. There was almost full agreement among those who testified that existing risk reduction measures are not working.
The first ever public hearing on the safety of marketed medicines being organized by the European Medicines Agency has drawn a “very positive” response from the members of the public who have applied to attend the event on Sept. 26. The agency is now shortlisting an appropriate mix of speakers and observers.