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.
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Warning of counterfeit ivermectin tablets sold via social media
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.
Fighting antimicrobial resistance: a new antimicrobial medicinal product marketed in Belgium
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.
Marketing authorisation holders: mandatory update of contact details in product information for reporting adverse reactions to the FAMHP
The current postbox address of the FAMHP is no longer applicable.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.
PRAC March 2024 – PRAC finds no link between postmenopausal bleeding and mRNA COVID-19 vaccines
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.
Give your opinion on a genetically modified medicine for the treatment of hemophilia B
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.
PRAC February 2024: reminder of serious adverse reactions when Paxlovid is taken in combination with certain immunosuppressants
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.
Give your opinion on a genetically modified medicine for the treatment of limb girdle muscular dystrophy
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9003 for the treatment of limb girdle muscular dystrophy. The public consultation runs from 14 February 2024 to 14 March 2024.
PRAC January 2024: precautions for children whose father used a valproate-based medicine
During its January 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommends precautionary measures regarding the potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines.
Flash VIG-news: Gabapentin (Neurontin and generics) : risks of misuse, abuse, and dependence
The Summary of Product Characteristics (SPC) and package leaflet for gabapentin-containing medicines (Neurontin and generics in Belgium) have been updated following analyses of the risks of misuse, abuse and dependence.