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: New marketing authorisations in October 2022
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New Marketing Authorisations
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Product name and target species
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Active substance
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Authorisation Holder, territory, and distribution category
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Therapeutic group
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Food animals
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Xylexx 20 mg/ml solution for injection for cattle, horses, dogs and cats
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Xylazine
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Alfasan Nederland B.V.
POM-V
Authorised in NI
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Neurological Agent sedative
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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.
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.ure. Unless you have been advised otherwise, the labelling instructions on the pack which is dispensed should be followed.
For more information, contact the VMD at postmaster@vmd.gov.uk