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 July 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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GentaDug 85 mg/ml Solution for Injection for Horses, Cattle, Pigs, Dogs and Cats
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Gentamicin sulphate
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Bela-Pharm GmbH & Co. KG
NI
POM-V
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Antimicrobial
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Novel active substances
Recudon 2.5 mg/ml + 0.125 mg/ml Solution for Injection for Horses and Dogs
Recudon 5.0 mg/ml + 0.25 mg/ml Solution for Injection for Horses and Dogs
The first product authorised containing levomethadone and fenpipramide, authorised in horses and dogs, indicated for analgesia and premedication before procedures.
Changes to MAs
Cronyxin 50 mg/g Oral Paste for Horses
Bimeda Animal Health Limited GB & NI POM-V
Section 3.5 (NI) and 4.5 (GB): 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 4.2 (NI) and 5.2 (GB): Flunixin is toxic to avian scavengers although foreseen low exposure leads to low risk.
Norodine 24 Solution for Injection [for use in cats, cattle, dogs, horses, pigs]
Norbrook Laboratories Limited UK POM-V
Section 4.5: 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 Horses, Cattle, Pigs, Dogs, Cats during pregnancy, lactation, lay 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.
Pyroflam 50 mg/ml Solution for Injection for Cattle, Horses and Pigs
Norbrook Laboratories Limited 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: Flunixin is toxic to avian scavengers although foreseen low exposure leads to low risk.