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

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.

Microphones
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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Drug Safety

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By 

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By 

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

More from Pink Sheet

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By 

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

Citeline Japan Awards 2025 - Enter Now!

 

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.