Portal Veterinary medicinal products

The availability of GS-441524 by pharmacies has raised questions. The French agency for veterinary medicinal products (ANMV) has long been involved in the issue of the therapeutic gap related to feline infectious peritonitis (FIP), in collaboration with the Monitoring committee for veterinary medicinal products. In particular, it has worked to ensure that the use of Remdesivir is not excluded in veterinary medicine at European level. At the same time, the ANMV informed stakeholders of the various legal gateways to therapeutic solutions, including dispensers' preparations.

SENVELGO® (velagliflozin) 15 mg/ml - oral solution for cats - has been granted a marketing authorisation by the European Commission in November 2023. At the request of the European Medicines Agency and, for France, the National agency for veterinary medicinal products, Boehringer Ingelheim Vetmedica GmbH disseminates information on the occurrence of serious adverse reactions and how to prevent them.

Birds of prey and other scavenging animals may accidentally be exposed to veterinary medicines when they eat the carcasses of animals that are not rendered and have therefore been left in the wild. Certain anti-inflammatories and barbiturates pose a particular risk. The French Agency for Veterinary Medicinal Products (ANMV) is calling on veterinarians and breeders to take all the necessary precautions when administering these drugs to animals liable to be consumed by scavengers after their death.

Paragraph 13 of Article 58 of European Regulation 2019/06 specifies that the marketing authorisation holder shall without delay inform the competent authority which has granted the marketing authorisation or the Commission, as applicable, of any action which he intends to take in order to cease the marketing of a veterinary medicinal product prior to taking such action, together with the reasons for such action. The planned suspension or withdrawal the marketing marketing authorisation shall be declared to the ANMV as far in advance as possible, if possible 12 to 24 months before the last batches are no longer marketed. This declaration use the reporting template available on the ANSES website. The corresponding email should be sent to DQ_ANMV@anses.fr . Declaration sheet After examining the data provided, the impact of the marketing suspension on the national market is assessed by Anses-ANMV. In the event of a major impact, the search for transitional and alternative measures is continued. At the same time, the SIMV is informed of the withdrawal of MA project, with the agreement of the marketing authorisation holder (or its representative). Manufacturers interested in taking over marketing authorisations can then directly contact the SIMV (contact@simv.org). “ Good practices for the management of these declarations ” specify the actions to be taken by each of the participants as well as the modalities of exchanges. The advance declarations do not replace the official information to the ANMV (enreg@anses.fr) on the abandonment of marketing authorisation, which will be completed in the month preceding the exact date of abandonment.