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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.

Federal Agency for Medicines and Health Products bids farewell to chief executive officer Xavier De Cuyper

Xavier De Cuyper, chief executive officer of the Federal Agency for Medicines and Health Products, will retire on 1 September 2023. He has been the head of the Belgian medicines agency since 1 May 2007 and had reached the age limit for holding a mandate position in the federal government in 2022. Xavier De Cuyper's mandate expired on 1 March 2022 but to ensure the continuity of the FAMHP's operations and stability, it was extended.

Valproate and its derivatives (Depakine and generics): European risk assessment of children whose fathers used valproate or a derivative

A retrospective observational study is currently being conducted by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency on the risks to children born to fathers exposed to valproate or one of its derivatives during the three months prior to conception. The recommendations and restrictions on the use of valproate and its derivatives during pregnancy, and measures to avoid in utero exposure to medicinal products containing valproate or its derivatives remain in force and unchanged.

Fight against antimicrobial resistance: conditions use critical antibiotics extended to all animals and use of antibiotics is now also monitored in cattle and all chicken and turkey species

From now on, veterinarians must also record data on the use of antibacterial medicinal products in cattle and all chicken and turkey species. The condition for which the medicinal product is used must also be described. In addition, the prerequisites for the use of critical antibiotics are extended to all animals, thus including companion animals and horses. Laboratories must meet new quality standards to perform antibiogram tests.

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