New MAs and changes made and published to end of July 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 July 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
| Product Name |
Active Substance |
Authorisation Holder |
Public Assessment Report to be made available from VMD? |
|
Ketabel 100 mg/ml solution for injection
Authorised for use in cats, cattle, dogs, goats, guinea pigs, hamsters, horses, mice, pigs, rabbits, rats, sheep |
Ketamine |
Bela-Pharm GmbH & Co. KG |
No - RMS France |
| Oxtra DD 100 mg/ml solution for injection for cattle, sheep, pigs, horses, dogs and cats |
Oxytetracycline |
Support Pharma S.L |
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.