Belgium FAMHP News

PRAC Warns of Ixchiq Vaccine Aseptic Meningitis Risk in Healthy Young Adults

PRAC completed its review of a safety signal of aseptic meningitis with Ixchiq (live attenuated chikungunya vaccine) and recommended updating the product information to reflect that serious side effects such as aseptic meningitis have also been observed in healthy young adults. Previously, most reported cases had occurred in older people (over 65 years of age) or those with multiple long-term conditions. PRAC is also conducting a periodic safety update report assessment concluding in June 2026.

Fibclot 1.5g Unavailable Until Jan 2027, 25% Consumption Reduction Required

The FAMHP task force Unavailability has issued recommendations due to the temporary unavailability of Fibclot 1.5g from 9 October 2025 until 31 January 2027. All Belgian hospitals are requested to reduce overall human fibrinogen consumption by at least 25% to ensure continued treatment for highest-priority patients. Alternative products Fibryga 1g and Riastap 1g remain available but cannot fully meet expected needs.

EU Article 10a MDR/IVDR Decision Tree for Marketing Interruption Notification

The European Commission published a decision tree to guide economic operators—including manufacturers and agents—on applying Article 10a of EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). The tool clarifies when ending or interruption of medical device or in vitro diagnostic marketing requires notification to FAMHP. Economic operators should use this decision tree to determine their reporting obligations before notifying the Belgian authority.