VMD Medicines Update - March 2023

Medicines Update: March 2023

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 March 2023

TABLE 1: New marketing authorisations in March 2023

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 at www.gov.uk/check-animal-medicine-licensed.

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

Supaverm Oral Suspension

Elanco Europe Ltd.           UK          POM-VPS

Section 4.5i: As overdosage may result in signs of toxicity such as incoordination and blindness, care should be taken to ensure animals are not overdosed by volume. If the product is spilled, care should be taken to ensure animals do not ingest it.

Section 4.5ii: This product may be irritating to skin and eyes and users should be careful not to accidentally splash it on themselves or others. Wear impermeable rubber gloves when applying the product. Remove any contaminated clothing immediately. In case of accidental spillage onto skin or into eyes, rinse the affected area with large amounts of clean water. If irritation persists, seek medical advice immediately and show the package leaflet or label to the physician.

Section 4.5iii: This product is toxic to aquatic organisms and dung insects. Long-term effects on dung insects caused by continuous or repeated use cannot be excluded. Repeat treatments on a pasture within a season should only be given on the advice of the prescriber. To reduce the risk for dung fauna, if the worming protocol allows, treated and untreated animals should be grazed on the same field. The risk to aquatic ecosystems will be reduced by keeping treated animals away from water bodies for 48 hours after treatment.

Switch 4% w/v Pour-on Solution

VetPlus Ltd                          UK          AVM-GSL             Donkeys, Horses

Section 4.5ii: The product may cause neurotoxic effects and skin and eye irritation.  Wash splashes from the skin and eyes immediately.  If eye irritation persists, seek medical advice immediately and show the package leaflet or the label to the physician.

Emdofluxin 50 mg/ml, Solution for Injection for Cattle, Pigs and Horses

Emdoka 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.

For more information, contact the VMD at postmaster@vmd.gov.uk