New MAs and changes made and published to end of August 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 August 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 https://www.gov.uk/check-animal-medicine-licensed
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 on http://www.ema.europa.eu
TABLE 1
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Marketing Authorisations issued/published in August 2020
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Product name
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Active substance
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Authorisation Holder
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Public Assessment Report to be made available from VMD?
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|
Bimeprazol 370 mg/g oral paste for horses
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Omeprazole
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Oy Medfiles Ltd
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Yes
|
|
Emdofluxin 50 mg/ml, solution for injection for cattle, pigs and horses
|
Flunixin
|
Emdoka bvba
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No – RMS France
|
|
Peptaleve 370 mg/g oral paste for horses
|
Omeprazole
|
Norbrook Laboratories (Ireland) Limited
|
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