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 2024
TABLE 1: New marketing authorisations in August 2024
|
New Marketing Authorisations
|
|
Product name and target species
|
Active substance
|
Authorisation Holder, territory, and distribution category
|
Therapeutic group
|
|
Food Animals
|
|
Flunex 50 mg/ml Solution for Injection for Cattle, Pigs and Horses
|
Flunixin
|
Livisto Int'l, S.L.
NI, POM-V
|
Anti Inflammatory NSAID
|
|
Triquest 333 mg/ml + 67 mg/ml Oral Suspension for Horses
|
Trimethoprim, Sulfadiazine
|
Alfasan Nederland B.V.
GB & NI, POM-V
|
Antimicrobial
|
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 is listed, along with the authorisation holder, distribution category and details of which Summary of Product Characteristics (SPC) sections have been revised/changed.
Changes to the SPC, labels and leaflets may change how the medicines should be used. Details can be found on the VMD’s Product Information Database (PID) here.
Due to ongoing assessments, there may be a delay between the point at which a new change is authorised and the updated SPC being available on the PID. There may also be a delay between the point at which any SPC changes are authorised and implementation in the product literature. Unless you have been advised otherwise, the labelling instructions on the pack which is dispensed should be followed.
Oxtra DD 100 mg/ml Solution for Injection for Cattle, Sheep, Pigs, Horses, Dogs and Cats
Fatro S.p.A. GB & NI POM-V
Section 4.12 (GB) and 3.12 (NI): Change to the withdrawal period for cattle and sheep milk when using the 24-hour dosage regimen: cattle milk 72 hours, sheep milk 120 hours.
For more information, contact the VMD at postmaster@vmd.gov.uk