New MAs and changes made and published to end of September 2020
The points below highlight changes in marketing authorisations (MAs) that may have a significant impact on veterinary surgeons’ prescribing decisions.
New marketing authorisations
New marketing authorisations relevant to veterinary surgeons in the UK that were issued or published in September are listed in Table 1.
Table 1 also indicates where a public assessment report should become available for a product. Where available, links to these reports are accessible by clicking on the relevant product on the VMD’s Product Information Database.
The European Medicines Agency (EMA) publishes European Public Assessment Reports (EPARs) for every veterinary medicine which is authorised through a centralised procedure. Links to these reports are accessible here.
TABLE 1
| Marketing Authorisations issued/published in September 2020 |
| Product name | Active substance | Authorisation Holder | Public Assessment Report to be made available from VMD?
|
| Danilon Equidos Gold 1.5 g granules for horses and ponies | Suxibuzone | Ecuphar Veterinaria S.L.U. | Yes |
| Primopen 300 mg/ml suspension for injection for cattle, pigs and horses | Procaine benzylpenicillin | Fatro S.p.A | No - RMS Ireland |
Please note that there may be a delay between the issuing of a marketing authorisation to a company and the product being placed on the market.
In prescribing these veterinary medicines, veterinary surgeons should be aware that changes to the Summary of Product Characteristics (SPC), labels and leaflets may, in certain cases, change how the medicines should be used. The timing of when such changes have to be taken into account will depend on the circumstances, but as a general rule unless a prescriber has been advised otherwise by the manufacturer or the VMD the labelling instructions on the pack from which the product is dispensed should be followed.
VMD contact for this article: Vivienne Saville; v.saville@vmd.gov.uk