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Direct Healthcare Professional Communication (DHPC) on hydroxyethyl starch (HES) solutions for infusion: measures to minimise risks associated with off-label use

2023.11.21

Active substance: hydroxyethyl starch

Following a decision by the European commission (EC) in May 2022 to suspend the licenses of HES-containing products due to still occurring significant off-label use (Germany deferred from the suspension for up to 18 months) the Federal Institute for Drugs and Medical Devices decided that the conditions for lifting the suspension are meanwhile fulfilled.
It is emphasized again that it is of utmost importance that HES-containing infusion solutions are used exclusively in the authorized indications and in accordance with the contents of the mandatory yearly training courses.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 187KB, File is accessible