During its April 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no available evidence supporting a link between GLP-1 receptor agonists and suicidal thoughts and thoughts of self-harm and advice to CHMP on new Rybelsus tablets.

On 17 and 18 April, the Federal Agency for Medicines and Health Products (FAMHP), the National Institute for Health and Disability Insurance (NIHDI) and the Health Care Knowledge Centre (KCE) organised a high-level conference on health-related needs as drivers for healthcare policy and innovation. This conference was organised in the context of the Belgian presidency of the Council of the EU. The aim is to establish a research and innovation ecosystem that focuses on the most pressing health needs.

The FAMHP and Sciensano are warning about counterfeit ivermectin tablets that are being used for self-medication against COVID-19. Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day.

In the fight against antimicrobial resistance, it is important to improve the diversity of therapeutic treatments to enable medical doctors to make the most appropriate choice. Maribavir, a new viral active substance, has recently been launched on the Belgian market.

The current postbox address of the FAMHP is no longer applicable. The contact details for reporting adverse reactions to the FAMHP should be changed by marketing authorisation holders in the product information of medicinal products for human use as soon as possible.

During the March 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that there is no link between postmenopausal bleeding and mRNA COVID-19 vaccines.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine PF-06838435 for the treatment of hemophilia B. The public consultation runs from 28 February 2024 to 28 March 2024.

During its February 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency reminded healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid when used in combination with certain immunosuppressants.