VMD Medicines Update - February 2022

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 February 2022.

TABLE 1: New marketing authorisations in February 2021

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

Rifen 100 mg/ml solution for injection for horses, cattle and swine

Richter Pharma AG                          GB & NI POM-V

Section 4.2: For the relief of post-operative pain associated with dehorning in calves.

Section 4.4: Treatment of calves with ketoprofen before dehorning reduces post-operative pain. Ketoprofen alone will not provide adequate pain relief during the dehorning procedure. To obtain pain relief during dehorning co-medication with an appropriate local anaesthetic is needed.

Section 4.6: In very rare cases, hypersensitivity reactions may occur. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening and should be treated symptomatically.

Section 4.9: For the relief of post-operative pain associated with dehorning the product should be administered as a single injection intravenously or deep intramuscularly 10 – 30 minutes before the procedure.

In cattle, the volume per injection site for IM injection should not exceed 9 ml. If the injection volume exceeds 9 ml, this volume should be divided into multiple doses, administered at different injection sites.

Section 4.11: Changes to the withdrawal periods:

Meat and offal:

Horse:   IV            1 day (24 hours)

Cattle:   IV            1 day (24 hours)

                                IM          3 days (72 hours)

Pigs:                       IM          4 days

Milk (cattle):       Zero hours

Not authorised for use in mares producing milk for human consumption.

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