24.11.2023 - Updated information on the marketability of medicinal products containing HES

Fresenius Kabi Deutschland GmbH has fulfilled the conditions set out in Annex III of the European Commission's Implementing Decision. The suspension of the affected HES-containing marketing authorizations of Fresenius Kabi Deutschland GmbH will therefore not be ordered. In the meantime, B. Braun Melsungen AG has withdrawn its HES-containing marketing authorizations. Due to the waiver, these authorizations have been deleted and can therefore no longer be suspended.

13.06.2022 - European Commission final decision

Decision of the European Commission on the suspension of marketing authorizations for infusion solutions containing hydroxyethyl starch (HES); entry into force of the suspension decision

Following the entry into force of the European Commission's decision to suspend marketing authorizations for infusion solutions containing hydroxyethyl starch (HES), Germany will use a transition period of 18 months.

15.04.2019 - Information for health professionals

On 15.04.2019, the experts were informed about the details of the programme for controlled access to medicines containing HES in order to strengthen the existing restrictions.

27.03.2019 - Controlled access program details

Due to numerous inquiries, the BfArM provides further information on the program for controlled access to drugs containing 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.

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 - Procedure started

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.

Further information

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

To the risk assessment procedure (available in German only)