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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.

The FAMHP encourages healthcare professionals and patients to notify medication errors

Medication errors can occur at any stage in the medicine circuit: during prescribing, dispensing, storing, preparing and administering. They pose a major public health problem.

Reminder - Deadline for registration of annual sales volume data for veterinary medicinal products

Marketing authorisation holders have until 29 February 2024 to submit annual sales volume data for veterinary medicinal products for 2023.

Update of the Belgian regulatory guidance on the use of GMOs in clinical trials

The FAMHP and Sciensano are making available a Belgian regulatory guidance on the use of genetically modified organisms in clinical trials.

The FAMHP is ready for the Belgian presidency of the Council of the European Union

From 1 January to 30 June 2024, Belgium is holding the presidency of the Council of the European Union. The presidency in the area of public health will focus on three major themes: care, preparedness and protection. The FAMHP will use this opportunity to put our priorities on the European agenda and to help define European health policy for the coming years.

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.

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