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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 March 2018 are listed in Table 1.
Of those products listed, the VMD draws attention to:
Proin 15 mg / 50 mg chewable tablets for dogs, contains the active substance phenylpropanolamine hydrochloride in a new pharmaceutical form of chewable tablets. The product is indicated for the management of urinary incontinence associated with urethral sphincter incompetence in the bitch, particularly that associated with ovariohysterectomy.
Tralieve 50 mg/ml solution for injection for dogs is the first product containing the new active substance tramadol hydrochloride authorised for use in dogs. The product is indicated for the reduction of mild postoperative pain.
Vigophos 100 mg/ml +0.05 mg/ml solution for injection for cattle contains the new active substance butafosfan in combination with cyanocobalamin. The product is indicated for the supportive treatment of secondary ketosis (eg, in abomasal displacement).
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 www.gov.uk/check-animal-medicine-licensed
About this report
This summary forms part of a continuing series of monthly updates for Vet Record from the Veterinary Medicines Directorate. The last summary was published in VR, 21 April 2018, vol 182, pp 450-452.
The European Medicines Agency publishes European Public Assessment Reports for every veterinary medicine that is authorised through a centralised procedure. Links to these reports are accessible at www.ema.europa.eu
There may be a delay between the issuing of a marketing authorisation to a company and the product being placed on the market.
Changes to marketing authorisations
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