Market authorisation holders for medicines for human use must follow certain labelling and packaging guidelines. These guidelines are being amended.
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January 2018 PRAC - conclusion of the new reassessment of drip solutions containing hydroxyethyl starch (HES)
During its meeting of January 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded the new reassessment of drip solutions containing hydroxyethyl starch (HES) that began in October 2017. The PRAC recommends suspending their marketing authorisations (MA).
Flash VIG-news: SACCHAROMYCES BOULARDII (in Belgium: ENTEROL®): risk of fungaemia and contraindication for seriously ill or immunosuppressed patients
Saccharomyces boulardii-based medicinal products are now contraindicated for seriously ill or immunosuppressed patients due to a risk of fungaemia.