New MAs and changes made and published to end of December 2020
The points below highlight changes in marketing authorisations (MAs) that may have a significant impact on veterinary surgeons’ prescribing decisions.
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.
Changes made to authorisations
Prascend 1 mg tablets for horses
(Pergolide) (Boehringer Ingelheim Animal Health UK Ltd)
The following additional user safety warnings are now included in section 4.5ii of the SPC: ‘Pergolide, like other ergot derivatives, may cause emesis, dizziness, lethargy or low blood pressure. Do not ingest the product. Store this product separately away from human medicinal products and handle this product with great care to avoid accidental ingestion. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Avoid driving or operating machinery following ingestion of this product.’
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