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 August 2023
Novel active substances
Senvelgo 15 mg/ml Oral Solution for Cats is the first product authorised containing Velagliflozin, a sodium-glucose co-trans
porter 2 (SGLT-2) inhibitor, indicated for the treatment of diabetes mellitus in cats.
TABLE 1: New marketing authorisations in August 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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Catophos 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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CP Pharma Handelsgesellschaft mbH
NI
POM-V
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Vitamin; Mineral
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Presedine 10 mg/ml Solution for Injection for Horses
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Detomidine hydrochloride
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Alfasan Nederland B.V.
GB
POM-V
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Neurological Agent sedative
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Presedine 10 mg/ml Solution for Injection for Horses and Cattle
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Detomidine hydrochloride
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Alfasan Nederland B.V.
NI
POM-V
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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. 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
Molemec Plus Paste for Horses 15.5 mg/g / 77.5 mg/g Oral Paste
Boehringer Ingelheim Animal Health UK Ltd GB POM-VPS
Section 4.6: Digestive discomfort (colic, loose stool) has been observed in very rare cases based on post-marketing surveillance data.
For more information, contact the VMD at postmaster@vmd.gov.uk