top of page
  • Regulatory House

PRAC recommends the suspension of the MA for HES solutions for infusion in the EU

Based on the studies, that were conducted and in view of the serious risks that certain patient populations are still exposed to, EMA’s safety committee (PRAC) has recommended that marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union (EU).

For more information see this link.

1 view0 comments

Recent Posts

See All

Which products cannot be registered?

SÚKL has published several types of products on its website for which it is no longer possible to apply for registration as a medicinal product, as they do not meet the definition under Section 2 of A


bottom of page