News FAMHP

The FAMHP is updating the guidance document to assist clinical trials sponsors as part of the pilot project for clinical trials in Belgium.

Last year, the e-PIL pilot project on the electronic patient information leaflet started. Hospital pharmacists will soon receive a link to an online survey to evaluate the project, one year after its start.

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.

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 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.

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 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

During its meeting of May 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral for Xeljanz (tofacitinib). PRAC has issued restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs.

Through possible limited availability of intravenous immunoglobulins, there is a threat of a shortage in some hospitals in Belgium. The Federal Agency for Medicines and Health Products (FAMHP) is giving recommendations for hospital pharmacists and physician-specialists within the hospitals.