The medicinal product Fibclot 1.5 g is temporarily unavailable from 9 October 2025 until 31 January 2027. The task force Unavailability of the FAMHP makes recommendations to physician specialists and hospital pharmacists.
The company Laboratoire français du Fractionnement et des Biotechnologies S.A. (LFB), marketing authorisation holder of the medicinal product Fibclot 1.5 g (based on the active substance human fibrinogen), has informed the FAMHP of a temporary unavailability of Fibclot 1.5 g from 9 October 2025 until 31 January 2027.
In Belgium, three medicinal products based on human fibrinogen are authorised and marketed:
- Fibclot 1.5 g;
- Fibryga 1 g;
- Riastap 1 g.
Fibryga 1 g (Octapharma Benelux SA-NV) and Riastap 1 g (CSL Behring GmbH) remain available. However, due to the unavailability of Fibclot, the expected needs for human fibrinogen in Belgium cannot be fully met until the end of January 2027.
In order to continue to guarantee the availability of human fibrinogen in Belgium, a collective rationalisation of consumption will be necessary in the coming months. This should ensure that hospitals normally supplied with Fibclot can rely on Riastap and Fibryga during the coming months.
The experts of the FAMHP’s task force Unavailability make the following recommendations to physician specialists and hospital pharmacists:
- reduction of consumption by at least 25 %.
All hospitals are requested to reduce the overall consumption of human fibrinogen by at least 25 % in order to ensure continued treatment for the highest‑priority patients.
- Absolute priority should be given to patients with congenital hypo‑ or afibrinogenaemia, for whom no alternative treatment options are available.
- Administration of human fibrinogen should be limited to severe bleeding and should only take place after objective confirmation of hypofibrinogenaemia (measurement of fibrinogen levels and/or use of thromboelastography).
- Alternative treatment options should be considered, such as plasma administration.
- Where applicable, unnecessary blood loss should be avoided and the principles of patient blood management (PBM) should be applied.
Monitoring by the FAMHP
The task force of the FAMHP relies on the sense of responsibility of all healthcare professionals involved in order to manage this critical situation. The FAMHP is closely monitoring the situation and planned deliveries and remains in regular contact with the companies concerned and the European Medicines Agency.