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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The current postbox address of the FAMHP is no longer applicable.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.

Give your opinion on a genetically modified vaccine for the prevention of rabies

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified vaccine PLLAV-YF17D/RabG for the prevention of rabies. The public consultation runs from 20 December 2023 to 19 January 2024.

PRAC November 2023 – Conclusion regarding available evidence not supporting link between the glucagon-like peptide-1 (GLP-1) receptor agonists and thyroid cancer

During its November 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that the available evidence does not support a causal association between the glucagon-like peptide-1 (GLP-1) receptor agonists - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and thyroid cancer.

Ozempic: modification of the recommendations for medical doctors (specialists) and (hospital) pharmacists due to limited availability

There is limited availability of the medicine Ozempic (semaglutide-based solution for subcutaneous injection) due to an acute increase in demand. This limited availability will certainly last until early 2024. Rybelsus (semaglutide-based tablets) is also unavailable. The experts from the FAMHP's Unavailability Task Force adapt the recommendations.

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