News FAMHP

Brexit has led to a larger number of files relating to changes in Reference Member State (RMS). A new template has accordingly been developed to streamline this process.

During its meeting of April 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a review of the risk of dosing errors with methotrexate medicines. The PRAC decided to further consider unmet medical need for hydroxyethyl-starch (HES) solutions for infusion and will discuss its recommendation at its May 2018 meeting.

The FAMHP publishes a new version of the medicinal product database containing all medicinal products for human and veterinary use authorised in Belgium. You can also find information about the availability or temporary supply problems of medicinal products.

The company Kela Pharma has indicated that, due to production issues, its Maniprex® 250 mg coated tablets and Maniprex® 500 mg film-coated tablets will be unavailable for an indefinite period once current stocks have been exhausted. The stock of Maniprex® 500 mg has already been exhausted, and Kela Pharma predicts, based on normal circumstances, that the stock of Maniprex® 250 mg will be exhausted by June 2018.

EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta on basis of evidence indicating risk of serious inflammatory brain disorders.

The FAMHP (pharmaco-, materio-, haemo-, bio-) Vigilance Division has recently been informed by pharmacists of medication errors due to confusion between Depakine 300 mg/5 ml syrup and Depakine 300 mg/ml drinkable solution. The FAMHP wishes to draw the attention of health professionals and patients to this risk of confusion.

Market authorisation holders for medicines for human use must follow certain labelling and packaging guidelines. These guidelines are being amended.

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).

Saccharomyces boulardii-based medicinal products are now contraindicated for seriously ill or immunosuppressed patients due to a risk of fungaemia.