Information for consumers and health professionals on new drug warnings and other safety information, drug label changes, and shortages of medically necessary drug products.

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). These products were authorised as an addition to other treatments for plasma volume replacements following acute (sudden) blood loss.

Panel suggests introduction of cosmetovigilance to monitor safety of cosmetics. Official reiterates faith in HCQ, says use recommended after assessment.

Pharmacovigilance system requirements from 1 January 2021