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 following are for products authorised for use in horses:
Subestin 25 microgram/ml Oral Solution for Horses
Floris Animal Health Limited
Authorised in GB, POM-V, Respiratory expectorant
RenuTend suspension for injection for horses
Tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells (tpMSCs)
Boehringer Ingelheim Vetmedica GmbH
Authorised in GB, POM-V, Musculoskeletal
This product contains the novel active substance tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells.
The product is authorised in GB to restore fibre alignment in horses with superficial digital flexor tendon or suspensory ligament fibre disruption.
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.
Pen & Strep suspension for injection / Streptacare suspension for injection
Norbrook Laboratories Limited UK
Authorised for use in cattle, horses, pigs, sheep
Section 4.6: In rare cases, hypersensitivity reactions can occur and very rarely, these can be fatal.
For more information, contact the VMD at firstname.lastname@example.org