VMD Medicines Update - September 2025

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

The below table shows the new marketing authorisations for September 2025.

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.

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

Global Vet Health S.L.  GB         POM-V

Section 3.2 Indications updated:

Horses:

Alleviation of acute inflammation and pain associated with musculoskeletal disorders.

Alleviation of visceral pain associated with colic.

Adjunctive therapy of endotoxemia due to or as a result of post-surgical or medical conditions or diseases that result in impaired blood circulation in the gastrointestinal tract.

Reduction of pyrexia.

Section 3.3: Do not use if haematopoiesis or haemostasis is impaired.

Section 3.7:

Pregnancy: The safety of the veterinary medicinal product has been established in pregnant cows and sows. Do not use the veterinary medicinal product within 48 hours before expected parturition in cows and sows.

The safety of the veterinary medicinal product has not been established in pregnant mares. Do not use during the whole of the pregnancy.

Laboratory studies in rats have revealed fetotoxicity of flunixin after intramuscular administration at maternotoxic doses as well as an extension of the gestation period. 

The veterinary medicinal product must be used within the first 36 hours postpartum only following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placenta.

Fertility: The safety of the veterinary medicinal product has not been established in bulls, stallions and boars intended for breeding. Do not use in breeding bulls, breeding stallions and breeding boars.

Section 3.12: Withdrawal periods changed:

Horses:

Meat and offal: 5 days (intravenous use)

Milk: Not authorised for use in animals producing milk for human consumption

Further extensive updates to sections 3.5 (target species and user safety warnings), 3.6 (Adverse events), 3.9 (Administration routes and dosage) and 3.10 (Symptoms of overdose). Refer to product SPC for details.

Euthanimal 20%, 200 mg/ml / 40%, 400 mg/ml Solution for Injection

Alfasan Nederland B.V. GB & NI               POM-V

Addition of new target species and associated dosing information.

Original target species: pigs, goats, sheep, cattle, horses, cats and dogs

Additional new target species: rabbits, guinea pigs, mice, rats, hamsters, chickens, pigeons, ducks, small ornamental birds, snakes, turtles, lizards and frogs.

Pergoquin 1 mg Tablets for Horses

VetViva Richter GmbH GB & NI POM-V

Section 3.5: Extensive changes to user safety warnings. Refer to product SPC for details.

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