06.06.2019 - CMDh position

The PRAC recommendation was adopted by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) by consensus and will be implemented directly at national level.

17.05.2019 - PRAC recommendation

Recommendation on the withdrawal of marketing authorisations for medicinal products containing fenspiride

The Pharmacovigilance Risk Assessment Committee (PRAC) recommended the withdrawal of marketing authorisations for fenspirid at its May 2019 meeting.

15.02.2019 - Procedure started

Suspension of fenspiride medicines due to potential risk of heart rhythm problems

EMA’s safety committee (PRAC) has recommended an EU-wide suspension of fenspiride medicines, used in children and adults to relieve cough caused by lung diseases.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

To the risk assessment procedure (available in German only)