Vaccine againts epizootic haemorrhagic disease virus: second authorisation for use in Belgium

date: 30/01/2025

On 29 January 2025, the FAMHP authorises the use of the immunological veterinary medicinal product Syvac EH Marker (suspension for injection from the company Laboratorios SYVA, S.A.U.) intended for cattle.

From 29 January 2025, the immunological veterinary medicinal product Syvac EH Marker (suspension for injection from the company Laboratorios SYVA, S.A.U.) intended for cattle may be used in Belgium. The use of the immunological veterinary product is authorised under Article 110 (2) of Regulation 2019/6, for a period of one year or r as soon as the conditions set out in Article 110(2) of Regulation 2019/6 are no longer met.

A Regulatory Decree will follow in February 2025 that will impose the following conditions for the use of the abovementioned vaccine.

1.    The obligation to report adverse reactions to the FAMHP
Given the emergency situation and the limited data available, the reporting of adverse reactions is mandatory to get a clearer picture of the safety and efficacy of the vaccine in question.

Veterinarians must report any adverse reaction directly via the FAMHP's national reporting system for veterinary medicinal products.

2.    Vaccine distribution in Belgium
This vaccine is distributed through the usual distribution chain and is limited to the veterinarian's depot.

Fendigo will be the distributor and will deliver to wholesalers in Belgium.
 

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