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EMA Set To Adopt Safe-Use Recommendations For Anti-Epilepsy Drug Valproate

 
• By Vibha Sharma

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.

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Valproate was the subject of the EMA's first ever public hearing • Source: Shutterstock

The European Medicines Agency's pharmacovigilance committee (PRAC), which is meeting this week, is expected to adopt final recommendations on the anti-epileptic drug, valproate, to address ongoing concerns with its use in women and girls who are pregnant or of childbearing age.

The drug, originally from Sanofi but now widely available as a generic, was the subject of PRAC's first ever public hearing. The hearing took place last September, when the EMA's process of assessing medicines in the post-marketing phase was opened to the wider public for the first time

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