New marketing authorisations
Table 1 shows the new marketing authorisations for September 2024
New Marketing Authorisations | |||
Product name and target species | Active substance | Authorisation Holder, territory, and distribution category | Therapeutic group |
Food Animals | |||
Bovimox LA 100 mg/ml Solution for Injection for Cattle | Moxidectin | EU Pharmaceuticals Ltd GB & NI, POM-VPS |
Endectocide |
Moxodex LA 100 mg/ml Solution for Injection for Cattle | Moxidectin | EU Pharmaceuticals Ltd GB & NI, POM-VPS |
Endectocide |
Ridamec LA 100 mg/ml Solution for Injection for Cattle | Moxidectin | EU Pharmaceuticals Ltd GB & NI, POM-VPS |
Endectocide |
Non-food Animals | |||
Chanear Ear Drops and Cutaneous Suspension for Cats and Dogs | Miconazole nitrate, Prednisolone acetate, Polymyxin B sulphate | EU Pharmaceuticals Ltd GB & NI, POM-V |
Antimicrobial; Anti Inflammatory; Antimycotic |
Coxatab 25 mg / 100 mg / 225 mg Chewable Tablets for Dogs | Firocoxib | CP Pharma Handelsgesellschaft mbH GB, POM-V |
Anti Inflammatory NSAID |
Marbotis 3mg/ml + 10mg/ml + 1mg/ml Ear Drops, Suspension for Dogs | Dexamethasone, Clotrimazole, Dexamethasone acetate, Marbofloxacin | Vet-Agro Multi-Trade Company Sp. z o.o. GB & NI, POM-V |
Antimicrobial; Anti Inflammatory; Antimycotic |
YURVAC RHD Emulsion for Injection for Rabbits | Recombinant RHDV2 virus capsid protein | Laboratorios Hipra SA GB, POM-V |
Inactivated Viral Vaccine |
The timing of the product being placed on the market is an issue for the marketing authorisation holder.
Changes to authorisations most relevant to vets
The changes to authorisations most relevant to vets can be found below. Each product is listed, along with the authorisation holder, distribution category and details of which Summary of Product Characteristics (SPC) sections have been revised/changed.
Changes to the SPC, labels and leaflets may change how the medicines should be used. Details can be found on the VMD’s Product Information Database (PID) at www.gov.uk/check-animal-medicine-licensed.
Due to ongoing assessments, there may be a delay between the point at which a new change is authorised and the updated SPC being available on the PID. There may also be a delay between the point at which any SPC changes are authorised and implementation in the product literature. Unless you have been advised otherwise, the labelling instructions on the pack which is dispensed should be followed.
Food producing animals
Cydectin 20 mg/ml LA Solution for Injection for Sheep
Zoetis UK Limited GB & NI POM-VPS
Section 4.4 (GB) and 3.4 (NI): Psoroptes ovis is an extremely contagious external parasite of sheep and cattle. To ensure complete control, great care must be taken to avoid re-infestation, as mites may be viable for up to 15 days off the animal. It is important that all animals which have been in contact with infected ones are treated with an appropriate product. Contact between treated, infected and untreated herds must be avoided until at least seven days after treatment.
Resistance to moxidectin has been reported in Psoroptes ovis scab mites in sheep and in cattle. Cases of side-resistance with other macrocyclic lactones (ivermectin and doramectin) have been reported as well. The use of this product should take into account local information about susceptibility of the target parasites, where available.
Section 4.6 (GB) and 3.6 (NI): There has been a change to the frequency of the adverse event ‘neurological disorder (such as collapse, convulsion, paralysis)’ to ‘very rare’, with a related note added that severe reactions may be fatal.
Qualimec 5 mg/ml Pour-on Solution for Cattle
Eco Animal Health Ltd GB & NI POM-VPS
Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves and protective clothing should be worn when handling the veterinary medicinal product by women of childbearing age.
Section 4.7: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit/risk assessment by the responsible veterinarian.
Companion animals
Posatex, Ear Drops Suspension for Dogs
Intervet International BV NI POM-V
Section 3.9: Posatex is a viscous suspension. The inherent viscosity will result in a reduced delivery volume compared to the fill volume (see section 5.4). Further information on delivery volume in relation to fill volume for each pack size are provided in section 5.4.
For more information, contact the VMD at postmaster@vmd.gov.uk