This medicines update is provided by the Veterinary Medicines Directorate (VMD) and lists new active substance, new marketing authorisations and changes to authorisations most relevant to vets.
New marketing authorisations
Table 1 shows the new marketing authorisations for January 2023
TABLE 1: New marketing authorisations in January 2023
See the VMD’s Product Information Database for more information on each of these products. This includes separate links for the authorisation territories of Great Britain and Northern Ireland.
Please note, there may be a delay between the issuing of a marketing authorisation and the product being placed on the market.
Changes to authorisations most relevant to vets
The changes to authorisations most relevant to vets can be found below. Each product listed, along with the authorisation holder, distribution category and details of which Summary of Product Characteristics sections have been revised/changed.
All entries can be found on the VMD’s Product Information Database.
Changes to the SPC, labels and leaflets may change how the medicines should be used. There may be a delay between these changes being authorised to implementation on product literature. Unless you have been advised otherwise, the labelling instructions on the pack which is dispensed should be followed.
Food producing animals
Aservo EquiHaler 343 micrograms/actuation Inhalation Solution for Horses
Boehringer Ingelheim Vetmedica Gmbh GB POM-V
Section 4.5: Acclimatising the horse with a training device, available from the marketing authorisation holder, prior to treatment start has shown to ease the administration of the veterinary medicinal product. Surveillance has shown cases where the horses were non-cooperative and therefore could not be treated according to the product information. In case a horse has a tendency towards defensive behavioural reactions, additional safety precautions could be considered (e.g., employ a second person to handle the horse).
Dugnixon 50 mg/ml Solution for Injection for Cattle, Pigs and Horses
Global Vet Health S.L. GB & NI POM-V
Section 4.5: Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna.
Section 5.2: Environmental properties: Flunixin is toxic to avian scavengers although foreseen low exposure leads to low risk.
For more information, contact the VMD at postmaster@vmd.gov.uk