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Hydroxyethyl-starch containing Medicines: Introduction of new measures to protect patients

Date 2018.08.02
Active substance hydroxyethyl starch, HES

02.08.2018 - European Commission final decision

In its notice of 31 July2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2018) 4832 final of 17 July 2018.

29.06.2018 - CMDh position

The CMDh is introducing new measures in order to protect patients.

22.05.2018 - PRAC recommendation

The PRAC confirms its earlier recommendation for suspension of marketing authorisation.

12.04.2018 - Standing Committee on Medicinal Products for Human Use opinion

The BfArM issues information on the opinion of the Standing Committee for Medicinal Products for Human Use regarding HES within the European safety review in accordance with Article 107i of Directive 2001/83/EC for medicinal products containing HES

26.01.2018 - CMDh position

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