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 September 2023
TABLE 1: New marketing authorisations in September 2023
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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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Vey Tosal 100 mg/ml + 0.05 mg/ml Solution for Injection for Horses, Cattle, Dogs and Cats
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Butafosfan, Cyanocobalamin
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Veyx-Pharma GmbH
NI
POM-V
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Vitamin; Mineral
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See the VMD’s Product Information Database for more information on each of these products. There may be a delay before formal documentation is available for some Northern Ireland products, from the European Medicines Agency.
The timing of the product being placed on the market is an issue for the marketing authorisation holder.
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
Animeloxan 20 mg/ml Solution for Injection for Cattle, Pigs and Horses
aniMedica GmbH GB & NI POM-V
Section 4.5: NSAIDs and other prostaglandin inhibitors are known to have adverse effects on pregnancy and/or embryofoetal development. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.
Section 4.7: The safety of the veterinary medicinal product has not been established in cattle and pigs during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.
For more information, contact the VMD at postmaster@vmd.gov.uk