Saturday, November 30, 2019

New marketing authorisations



Marketing Authorisations issued/published in October 2019



Product Name

Active ingredient

Authorisation Holder

Public Assessment Report to be made available from VMD?

Doxycare Flavour 40 mg tablets for cats and dogs


Ecuphar NV

No – RMS Ireland

Doxycare Flavour 200 mg tablets for cats and dogs


Ecuphar NV

No – RMS Ireland

Moxidectin (EU Pharmaceuticals) 1 mg/ml oral solution for sheep


EU Pharmaceuticals Ltd


Ovimox 1 mg/ml oral solution for sheep


EU Pharmaceuticals Ltd


Prednizol 5 mg tablets for dogs and cats


Millpledge Ltd


SimparicaTrio chewable tablets for dogs; 1.25-2.5kg; 2.5-5kg; 5-10kg; 10-20kg; 20-40kg; 40-60kg



Zoetis Belgium


Tramvetol 50 mg tablets for dogs

Tramadol hydrochloride


No – RMS Netherlands



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 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 on

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.



Changes to marketing authorisations


Small Animals


Advantage Spot-on solution range for dogs and cats

(Imidacloprid) (Bayer plc)


Section 4.5 of the SPC updated with the addition of the warning: ‘Imidacloprid is toxic to aquatic organisms.  To avoid adverse effects on aquatic organisms, treated dogs should not be allowed to enter surface water for 48 hours after treatment.’


Bravecto chewable tablets for dogs range plus Bravecto 500mg spot-on solution range for dogs

(Fluralaner) (Intervet International) BV)


Section 4.2 of the SPC updated to include addition of the indication: ‘For the treatment of demodicosis caused by Demodex canis.’


Drontal Dog Tasty Bone 50mg / 144mg / 150mg tablets

(Febantel; Praziquantel; Pyrantel) (Bayer plc)


Section 4.6 of the SPC has been updated: ‘In very rare cases slight and transient digestive tract disorders such as vomiting and/or diarrhoea may occur.  In individual cases these signs can be accompanied by nonspecific signs such as lethargy, anorexia or hyperactivity.’


Ectoline Duo spot-on solution range for dogs and cats

(Fipronil; Pyriproxyfen) (Virbac Ltd)


Change of legal distribution category to NFA-VPS


Section 4.6 of the SPC has been update to include: ‘Transient cosmetic effects such as wet appearance or slight scaling may occur at the application site.

In very cases, according to the accumulated experience on these active ingredients

within spot on pharmaceutical forms, transient cutaneous reactions at the application

site (squamosis (scaling of the skin), local alopecia (hair loss), pruritus (itchiness),

erythema (redness of the skin), skin discolouration) and general pruritus or alopecia

may be observed after use. In very rare instances, hypersalivation, reversible

neurologic symptoms (hyperesthesia (increased sensitivity to stimuli), depression,

nervous symptoms), respiratory signs or vomiting might occur.’


Filavac VHD K C+V

(Rabbit haemorrhagic disease virus type 2) (Filavie)


Statement removed under "Special warning" on the SPC: "No information is available on the safety and efficacy in pet rabbits"



Food-producing animals


Buscopan Compositum solution for injection

(Hyoscine butylbromide; Metamizole) (Boehringer Ingelheim Animal)

This product is for use in cattle, horses and dogs


Section 4.6 of the SPC has been updated with the addition of the adverse reaction: ‘In very rare cases, anaphylactic reactions and cardiovascular shock can occur.’


Porcilis Ery suspension for injection for pigs

(Erysipelothrix rhusiopathiae) (Intervet UK Ltd)

Porcilis Ery+Parvo

(Erysipelothrix rhusiopathiae; Porcine parvovirus) (Intervet UK Ltd)


Section 4.6 of the SPC has been updated to include:

In laboratory studies and field trials:

Transient increases in body temperature (0.5°C) within 24 hours may very commonly occur.

Mild transient local swelling (Ø 1-10mm) until 8 days after vaccination may very commonly occur.

Transient reluctance to move may commonly occur.

In post marketing experience:

In very rare cases, a hypersensitivity reaction may occur.






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;

This post was last updated on