Notice Title

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:

  1. must state in full the reasons for making the submission;
  2. may state any decision sought on that application; and
  3. must be received by the Director-General no later than 30 working days after the date of this notice.

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:

  1. where submissions on this application are to be sent;
  2. where requests for copies of the public information relating to the application can be sent;
  3. where public information relating to the application can be viewed; and
  4. the Director-General’s address for service:

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).