News FAMHP

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Deadline for registration of annual sales volume data for veterinary medical products

Marketing authorisation holders have until the end of February 2024 to submit annual sales volume data for veterinary medical products for 2023.

Deadlines for the submission of dossiers during the end-of-year period

During the end-of-year period, the FAMHP will be closed from Monday 25 December 2023 to Monday 1 January 2024. Deadlines have been set for the submission of different types of dossiers.

Data Tracking System: new application for the effective management of marketing authorisation and vigilance dossiers

On 16 October 2023, the Data Tracking System (DTS) dossier will go live within the FAMHP. This application replaces four MeSeA applications. DTS provides additional functionalities that facilitate the effective management of dossiers in the context of marketing authorisation and vigilance.

PRAC October 2023 – New safety information for Omega-3-acid ethyl esters

During the October 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, recommends an update to the product information for medicines containing omega-3-acid ethyl esters, to inform healthcare professionals and patients of the risk of atrial fibrillation.

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.

Fighting antimicrobial resistance: new antimicrobial medicinal products marketed in Belgium

In the fight against antimicrobial resistance (AMR), it is important to improve the diversity of therapeutic treatments to enable medical doctors to make the most appropriate choice. A new dosage for children has recently been launched on the Belgian market for a pheneticillin-based antibiotic and two antivirals, one composed of bictegravir, emtricitabine and tenofovir and the other composed of dolutegravir, abacavir and lamivudine.

Unavailability of high-dose methotrexate: situation normalised, recommendations lifted

The supply of high-dose methotrexate, used in oncology, was temporarily limited worldwide. The situation has since returned to normal, allowing the task force's recommendations to be lifted.

Hugues Malonne is the FAMHP's new Chief Executive Officer

Hugues Malonne appointed new FAMHP Chief Executive Officer by the federal government

PRAC September 2023 – New measures recommended to avoid topiramate exposure in pregnancy

During its September 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy.

Customs and the FAMHP seize 1.5 tonnes of illegal medicines

On 14 July 2023, customs and the FAMHP seized 1.5 tonnes of illegal medicines at Brucargo. This is one of the largest seizures in the European Union in recent years.

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