Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI ACVM 95)
Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to vary the conditions of a registered trade name product under section 9(2) of the Act:
Trade Name: Cortavance
Registration Number: A010060
Active Ingredient and Concentration:
0.584mg/mL hydrocortisone aceponate
Formulation Type: Vapour releasing product
Application method/administration route: The recommended dose is 1.52 µg/cm2 of hydrocortisone aceponate once daily. This dosage can be achieved with two pump spray activations over a surface to be treated, equivalent to a 10 cm x 10 cm square. For relief of inflammatory and pruritic dermatoses, repeat the treatment daily for 7 consecutive days.
Existing Use Claim:
For topical use on dogs for the symptomatic relief of inflammatory and pruritic dermatosis, repeat the treatment daily for 7 consecutive days.
Proposed New Claim:
For topical use on dogs. For the symptomatic relief of inflammatory and pruritic dermatosis, repeat the treatment daily for 7 consecutive days. For the symptomatic treatment of Atopic Dermatitis. For treatment of atopic dermatitis, repeat the treatment up to 28 days. An intermediary control by the veterinarian at day 14 should be made. Once the clinical signs of atopic dermatitis are satisfactorily controlled, an extended duration of treatment beyond 28 days by daily, every-other-day or twice weekly administration must be left at the appreciation of the veterinary surgeon based on the risk-benefit assessment and regular clinical evaluations of the treated dog.
Any person may make a written submission to the Director-General concerning this application. Under sections 16 and 17 of the Act, a written submission:
Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the applicant.
The following address is:
ACVM Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.
MPI encourages submission by email.
The applicant’s address for service is:
Virbac New Zealand Limited, 26–30 Maui Street, Pukete, Hamilton 3200. Postal Address: PO Box 10305, Te Rapa, Hamilton 3241.
Dated at Wellington this 6th day of August 2025.
SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).