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The European Medicines Agency (EMA) is reassessing the risk of meningioma on medicines based on cyproterone, a risk that has long been known to medical professionals. A French study suggests that the risk of meningioma, even though small, can be greater in women who have taken high doses of cyproterone over long periods of time.

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.

The new Belgian Company Code, which concerns companies and associations, and which came into force on 1 May 2019, refers to only 4  corporate forms. This will have implications for some authorisations and registrations in the sense that holders thereof are now required to amend their documents.

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.

The Federal Service for Public Health, Food Chain Safety and Environment and the Federal Agency for Medicines and Health Products (FAMHP) want to know your opinion on vaccine plan B/BE/19/BVW4 which will be using a genetically modified vaccine against Ebola. This vaccine is meant to protect Belgian employees of Doctors Without Borders from Ebola in the Democratic Republic of the Congo. You can share your opinion until July 25.

During its meeting of June 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral for leuprorelin medicines. PRAC has started the review of handling errors with depot formulations of leuprorelin medicines