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PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch
Notice type:
3rd Party Publications
Date:
14/06/2013
Product name or type:
Infusion solutions containing hydroxyethyl-starch (HES)
Problem Or Issue:
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded following a review of the available evidence that the benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended.
The PRAC recommendation will be considered by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).
Background Information Or Related Documents:
PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch Document
Further Information:
For full EMA statement please refer to link below:
PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch
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Date Printed: 28/04/2024