15 jan 2024

Valproate paternal exposure – PRAC recommendationsalle nyheder

af Gitte Bramstorp

Dear representatives,

Our best wishes to you, your teams and your relatives for 2024.

Thank you again for contributing to the virtual stakeholder meeting on paternal exposure to valproate on November 16th, 2023.

We would like to inform you that EMA’s Safety Committee (PRAC) has now finalised the data evaluation and the corresponding recommendations have been published today on EMA website:

Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures | European Medicines Agency (europa.eu)

We would like to thank you again for your valuable contribution, which has been very useful to the PRAC in developing these recommendations.

Have a nice weekend and kind regards,

Public Engagement Department
Stakeholders and Communication Division
European Medicines Agency
Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
Telephone +31 (0)88 781 6000
public-engagement@ema.europa.eu | www.ema.europa.eu | For directions, see How to find us