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Infographic: key events


2 December, 2019  

A summary of the key European regulatory events regarding hydroxyethyl starches is presented


References

  1. European Medicines Agency. Article 31 referrals document. 20 November 2016. www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Solutions_for_infusion_containing_hydroxyethyl_starch/Procedure_started/WC500135590.pdf (accessed August 2019).
  2. European Medicines Agency. PRAC suspension recommendation. 14 June 2013. www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Solutions_for_infusion_containing_hydroxyethyl_starch/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500144448.pdf (accessed August 2019).
  3. European Medicines Agency. Hydroxyethyl starch solutions for infusion. 06 March 2014. www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Hydroxyethyl_starchcontaining_solutions/human_referral_prac_000012.jsp&mid=WC0b01ac05805c516f (accessed August 2019).
  4. Safety and efficacy of a 6% hydroxyethyl starch (HES) solution versus an electrolyte solution in trauma patients (TETHYS). https://clinicaltrials.gov/ct2/show/NCT03338218 (accessed August 2019).
  5. Safety and efficacy of 6% hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery (PHOENICS). https://clinicaltrials.gov/ct2/show/NCT03278548?term=PHOENICS&rank=2 (accessed August 2019).
  6. Rhodes A et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med 2017;43:304–77.
  7. European Medicines Agency. PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market. www.ema.europa.eu/en/news/prac-recommends-suspending-hydroxyethyl-starch-solutions-infusion-market (accessed August 2019).
  8. European Medicines Agency. Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation. www.ema.europa.eu/en/news/hydroxyethyl-starch-solutions-infusion-be-suspended-cmdh-endorses-prac-recommendation (accessed August 2019).
  9. European Medicines Agency. Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients. www.ema.europa.eu/en/news/hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients (accessed August 2019).