Annual Report 2018


During its meeting of July 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended new measures to avoid dosing errors with methotrexate. Furthermore, the PRAC started a review of meningioma risk with cyproterone medicines

In the context of pharmacovigilance activities, the FAMHP performed a survey of users of valproate in order to assess their knowledge of the risks associated with taking this medicinal product during pregnancy. The aim was to assess the new prevention measures implemented in Belgium in 2018, following the recommendations of the EMA (European Medicines Agency).

GSK can only produce 40% of the quantity of Clamoxyl I.V.-I.M. required each year because of a shortage of raw materials. The Federal Agency for Medicines and Health Products (FAMHP) and the National Institute for Health and Disability Insurance (RIZIV) are issuing recommendations for hospital pharmacists and hospital-based specialists.

The European Medicines Agency (EMA) has started a re-evaluation of medicinal products that contain leuprorelin (sold in Belgium under the name of DEPO-ELIGARD®). This re-evaluation comes in the wake of reports of errors during preparation and administration. As a result, some patients have not been able to receive their medication in sufficient doses, rendering their treatment less effective.

A scientific article has raised concerns about paclitaxel-coated balloons and paclitaxel-eluting stents used in the treatment of peripheral arterial disease (PAD). In response, the Federal Agency for Medicines and Health Products (FAMHP) hereby makes its recommendations.

Improved communication with partner organizations, increased accessibility to innovation for patients with urgent medical needs, an increasingly significant presence on social media … 2018 was marked by exciting developments for the Federal Agency for Medicines and Health Products (FAMHP). You can discover everything in the annual report.

Last updated on 29/06/2017