Maree Zinzley, Manager Approvals Operations, 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: Neptra Otic Solution
Active Ingredients and Concentrations:
14.8mg/mL terbinafine (equivalent to 16.6mg/mL terbinafine hydrochloride)
2.2mg/mL mometasone furoate
Formulation Type: Non-aqueous solution
General Use Claim:
NEPTRA® is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
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:
- must state in full the reasons for making the submission;
- may state any decision sought on that application; and
- 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:
- where submissions on this application are to be sent;
- where requests for copies of the public information relating to the application can be sent;
- where public information relating to the application can be viewed; and
- 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.
The applicant’s address for service is:
Bayer New Zealand Limited, 3 Argus Place, Hillcrest, Auckland 0627. Postal Address: PO Box 2825, Shortland Street, Auckland 1140.
Dated at Wellington this 10th day of June 2019.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).