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CDMh endorses PRAC recommendation to suspend marketing authorisations of medicinal products containing hydroxyethyl starch (HES)

Date 2018.01.26
Active substance hydroxyethyl starch, HES

26.01.2018 - CMDh recommendation

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed the recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to suspend the marketing authorisations of medicinal products for infusion containing HES across Europe.

12.01.2018 - PRAC recommendation

In the course of the European safety review according to Article 107i of Directive 2001/83 initiated in October of 2017, the Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of marketing authorisations for medicinal products for infusion containing hydroxyethyl starch (HES) in Europe.

27.10.2017 - start of procedure

The BfArM issues information on the initiation of a European safety review according to Article 107i of Directive 2001/83/EC regarding medicinal products containing HES. Studies show low adherence to restrictions aiming at reducing risks of kidney injury and death.

To the risk assessment procedure (available in German only)

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

Hydroxyethyl starch (HES) containing medicinal products