News FAMHP

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine CSL222 for the treatment of haemophilia B. The public consultation will take place from 28 April to 28 May 2025.

As announced in December 2024, Sanofi Belgium has decided to stop marketing Depakine 300 mg/5 ml syrup as of 28 April 2025. Depakine's other oral liquid formulation, the 300 mg/ml oral solution, will remain available in Belgium. As the latter is more concentrated than the syrup and dosed with a different device, patients, healthcare professionals and parents need to be informed and prepared to avoid potential medication errors.

Following an increased number of reports of anaphylactic reactions in horses after the administration of Genta-Equine 100 mg/ml, two batches are being recalled in Belgium. These are batches T-001 (expiry date 30 April 2025) and V-001 (expiry date 30 April 2026).

As not all veterinarians yet have prescriptions in line with the new legislation, the FAMHP has issued a circular asking its inspection services to no longer give priority to checking the conformity of these model prescriptions.

To better inform and raise awareness among Belgian citizens, the FAMHP launches its Instagram account where content suited to this platform will be shared: infographics, practical tips, news on medicines and healthcare products, and much more.

Certain progestins have been associated with an increased risk of meningioma. The FAMHP reminds healthcare professionals of measures to minimise the risk of meningioma associated with these progestins.

Are you a Belgian tissue establishment or hospital? From now on, you should report all serious adverse events (SAEs) and serious adverse reactions (SARs) to the FAMHP Biovigilance Entity using the new forms.

The European Commission has issued a second call for Member State laboratories to submit applications to become a European Union reference laboratory for in vitro diagnostic medical devices. The designation of these laboratories is provided for in Article 100 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

The FAMHP, EMA and the Heads of European Medicines Agencies warn about unregulated products in the EU, including dendritic cell cancer therapies.

Biovigilance ensures systematic monitoring, from donor selection to recipient follow-up, in order to guarantee safer and more efficient use of tissues and cells. In this 2023 report, all SAEs and SARs that occurred during the processing and use of SoHO from 1 January 2023 to 30 June 2024 have been compiled.