EMA to hold first public hearing in valproate safety review

EMA plans to hold a public hearing on Sept. 26 at which citizens are invited to share their experiences using valproate, a generic medicine approved to treat epilepsy, bipolar disorder and migraine.

The hearing is part of a review begun in March by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concerning valproate's safety in women and girls who are pregnant or of childbearing age. It is EMA's first public hearing as part of a PRAC safety review...