Bavarian Nordic, the company that holds the marketing authorisation for Rabipur (Powder and solvent for solution for injection in pre-filled syringe - Rabies virus (inactivated, strain Flury LEP)) has notified the FAMHP that the medicinal product will be unavailable until 31 August 2024 due to a delay in the release of the final product.
The Federal Agency for Medicines and Health Products (FAMHP) convened a task force with experts in order to find solutions.
The medicinal product Rabipur, used for active immunisation against rabies, will be in limited availability in Belgium till the end of August 2024.
Until the medicinal product becomes available again in sufficient quantities, the FAMHP, upon consultation with experts from the task force Unavailability, issues recommendations targeting physicians-specialists and hospital pharmacists.
- Rabipur is distributed only to approved travel clinics during this critical shortage.
- In the current critical shortage situation, Rabipur should be administered only in the following situations:
- Pre-exposure prophylaxis (PrEP)
Intramuscular injection of 2 doses with an interval of 7 days is recommended.
Immunocompromised patients should receive 3 doses on days 0, 7, and 28.
There will be a more restrictive selection of PrEP patients through a risk assessment. A PrEP treatment will require a risk assessment score of 5 (instead of 3 under normal circumstances).
For centres using intradermal administration, a risk score of 3 can be used as a threshold for whether or not to treat patients for PrEP. - Post-exposure prophylaxis (PEP)
Restrictive use is also advised for post-exposure prophylaxis.
Each travel clinic was asked about the (total) quantities needed to cover the shortage period. Based on a stock survey, quantities will be distributed to each centre to ensure treatment for priority patient groups.
The FAMHP closely monitors the situation, both at national and European level.