News

Limited availability of Visudyne 15 mg powder for solution for intravenous infusion: recommendations for (hospital) pharmacists and medical specialists

Due to a delay in production, the availability of Visudyne, a medicine used in ophthalmology, has been limited since 9 December 2024. This situation is expected to continue until at least the end of April 2026. The experts of the FAMHP’s Unavailability Task Force are making the following recommendations to (hospital) pharmacists and medical specialists.

Results of the thematic action on registration of medical device distributors on the FAMHP web portal

Distributors of medical devices are legally required to register with the Federal Agency for Medicines and Health Products (FAMHP). Between 2022 and 2024, the FAMHP inspection services conducted a thematic action in order to verify that. Thanks to this action, nearly four hundred distributors were registered on the FAMHP web portal.

PRAC June 2025 – The PRAC concluded its review of medicines containing semaglutide and is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella vaccines.

During its June 2025 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION). Furthermore, the PRAC is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella (chickenpox) vaccines, Varilrix and Varivax, following a report of a fatal outcome after vaccination with Varilrix.

Two additional children reported in the TP53 gene mutation dossier

After a fertility centre contacted the Federal Agency for Medicines and Health Products, it emerged that its dossier on the sperm donor carrying the TP53 gene mutation was incomplete, as two additional children were reported. FAMHP inspectors immediately visited the centre for an inspection. The procedure is still underway. The FAMHP considers that the fact that the centre is communicating these elements only now, despite previous information and questions, is very serious.

New: list of unavailable medical devices that could result (a risk of) serious harm

The FAMHP now publishes a list of medical devices and in vitro diagnostic medical devices notified under Article 10bis of regulations (EU) 2017/745 and 2017/746, introduced by the regulation (EU) 2024/1860. In other words, medical devices that are temporarily (interruption) or permanently (discontinuation) absent from the Belgian market and whose unavailability could result in serious harm or a risk of serious harm to patients or public health.