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 November 2022.
TABLE 1: New marketing authorisations in November 2022
New Marketing Authorisations
|
Product name and target species
|
Active substance
|
Authorisation Holder, territory, and distribution category
|
Therapeutic group
|
Food animals
|
Metaxx 20 mg/ml Solution for injection for cattle, pigs and horses
|
Meloxicam
|
Alfasan Nederland B.V.
Authorised in NI, POM-V
|
Anti Inflammatory NSAID
|
Synchromate 0.25mg/ml, Solution for injection for cattle and horses
|
Cloprostenol
|
Alivira Animal Health UK Ltd
Authorised in GB, POM-V
|
Prostaglandin
|
See the VMD’s Product Information Database (www.gov.uk/check-animal-medicine-licensed) 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 at www.gov.uk/check-animal-medicine-licensed.
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
Dugnixon 50 mg/ml Solution for injection for cattle, pigs and horses
Global Vet Health S.L. GB 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.
Imaverol 100 mg/ml Concentrate for cutaneous emulsion
AUDEVARD UK POM-VPS Cattle, Dogs, Horses
Section 4.5: Where possible, do not allow the animal to lick itself during treatment. Take care to avoid the animal inhaling the product or getting it into the eyes, nose or mouth.
Accidental ingestion of the product by animals may lead to adverse reactions (see section 4.6).
Strongid-P Paste 43.90% w/w
Elanco Europe Ltd GB POM-VPS Horses
Section 4.6: Impaction of the small intestine may occur in foals, infected with high numbers of Parascaris equorum. Symptoms (colic) may be seen as soon as 30 minutes after treatment.
For more information, contact the VMD at postmaster@vmd.gov.uk