Maree Zinzley, Manager Approvals, of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”) that the following application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: Mometamax Ultra

Reference: A011936

Active Ingredients and Concentrations:

Mometasone Furoate (as monohydrate) 2.1mg
Posaconazole 2.6mg
Gentamicin (as sulfate) per mL 8.6mg

Formulation Type: Non-aqueous suspension (Ear drops)

General Use Claim:

Mometamax Ultra Ear Drops Suspension for Dogs is a single application anti-inflammatory, antifungal and broad-spectrum antibacterial suspension indicated for the treatment of canine otitis externa associated with strains of bacteria susceptible to gentamicin (Pseudomonas aeruginosa, Staphylococcus pseudintermedius, Proteus spp., Streptococcus spp., Escherichia coli) and fungi susceptible to posaconazole (Malassezia pachydermatis).

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 notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

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 Group, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

The applicant’s address for service is:

Schering-Plough Animal Health Limited, 33 Whakatiki Street, Upper Hutt 5018. Postal Address: Private Bag 908. Upper Hutt 5140.

Dated at Wellington this 23rd day of February 2022.

MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).