Monday, January 6, 2020

New marketing authorisations

Marketing Authorisations issued/published in November 2019


Product Name

Active ingredient

Authorisation Holder

Public Assessment Report to be made available from VMD?

Calmino Vet, 380/60/50 mg/ml solution for infusion for cattle, sheep and pigs

Boric Acid;


Calcium Gluconate Monohydrate;


Magnesium Chloride Hexahydrate


Interchemie Werken De

No – RMS Estonia

Cocci Drench 2.5 mg/ml oral suspension


Elanco Europe Ltd


Equipred 50 mg tablets for horses



CP Pharma

No – RMS Netherlands

Porcilis Lawsonia lyophilisate and solvent for emulsion for injection for pigs

Lawsonia intracellularis

Intervet International BV

No – RMS France



Of note;

Calmino Vet, 380/60/50 mg/ml solution for infusion for cattle, sheep and pigs. This is the first product indicated for treatment of acute hypocalcaemia complicated by deficiency of magnesium in pigs.  The product is also indicated in cattle and sheep for this purpose.  The product contains the active substances calcium gluconate, magnesium chloride hexahydrate and boric acid.


Equipred 50 mg tablets for horses. These are the first tablets containing the active substance prednisolone approved for use in horses.  The product is indicated for alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO – severe asthma) in horses, in combination with environmental control.


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


Aurimic Ear Drops and cutaneous suspension for dogs and cats

(Miconazole nitrate; Polymyxin B sulphate; Prednisolone acetate) (Richter Pharma AG)


Section 4.5i of the SPC amended to include: ‘In cases of persistent infestations with Otodectes cynotis (ear mites) systemic treatment with an appropriate acaricide should be considered.’  Addition of the following warning to section 4.9: ‘The success of the treatment should be verified by a veterinarian before discontinuing treatment.’


Broadline Spot-on solution for cats

((S) Methoprene; Eprinomectin; Fipronil; Praziquantel) (Merial)


Section 4.6 of the SPC has been updated to include: ‘Transitory blindness or impaired vision have been observed in very rare cases based on post marketing safety experience.’


Food-producing animals


Ampredclav intramammary suspension for lactating cows

(Amoxicillin; Clavulanic acid; Potassium clavulanate; Prednisolone) (Norbrook Laboratories)


Addition of guidance to sections 4.9 and 4.11 of the SPC regarding use of the product in combination with a potentiated penicillin injectable product, Combiclav suspension for injection (Norbrook Laboratories Ltd).  Section 4.9 has been updated to contain recommendations on the treatment regime for combined therapy. 

Section 4.11 now states that when using this product and Combiclav suspension for injection in combination, the withdrawal period for meat and offal is 42 days and for milk is 84 hours from the last treatment of Combiclav suspension for injection, following the minimum posology regime.


Hyogen emulsion for injection for pigs

(Mycoplasma hyopneumoniae) (Ceva Animal Health Ltd)


Section 4.6 of the SPC has been updated to include: ‘On the day of vaccination a transient mean increase in body temperature of about 1.3°C is very common. In an individual pig this increase might reach 2°C, but in all cases body temperature is back to normal the next day.

A local reaction at the site of injection in the form of a swelling of a diameter up to 5 cm can be very common, which can last for three days. These reactions are of transient nature and do not need further treatment.

Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting. These clinical signs normally resolve without treatment.

Serious anaphylactic-type reactions (shock, recumbency) which may be fatal have been reported very rarely in post marketing experience. Such reactions require prompt symptomatic treatment.’


Nisinject suspension for injection

(Amoxicillin; Clavulanic acid; Potassium clavulanate) (Norbrook Laboratories)

Product for use in cattle and dogs


Section 4.2 of the SPC has been amended to add an indication for the treatment of mastitis in cattle.


Terramycin Aerosol Spray 3.92% w/w cutaneous spray

(Oxytetracycline hydrochloride) (Zoetis UK Ltd)

Product for use in cattle and sheep


Removal of advice to pare the hoof prior to topical administration for treatment of foot rot in sheep.




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;

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