Portal Veterinary medicinal products

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.

The issue of medicinal products supply shortages is a major topic for both animal and human health. In veterinary medicine, the holders or their representative (responsible for placing on the market) are obliged to report to Anses any risk of shortage of a veterinary medicinal product which could lead to a risk to human health, animal health or animal welfare.

The combined effects of climate disruption and human activities have created disturbances in the Earth’s ecosystems that are impacting the health of living organisms. Allergenic plants, mosquitoes and ticks have been spreading across France, affecting human and animal health. In forests, gardens and crops, plant pests and other harmful organisms are acclimatising rapidly. This year on the ANSES stand, we invite you to come take a closer look at these invasive species, so you can recognise them and protect yourself. Our programme for this year includes observation of living organisms, games and discussions with our scientists. And in a nod to this year's Olympic Games, ANSES will also provide an opportunity to learn while moving your body.