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 variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: Baytril 10% Injectable Solution

Reference: A5581

Active Ingredient and Concentration:

Enrofloxacin 100mg

Formulation Type: Aqueous solution

General Use Claim:

Anti-infective agent for the therapy of diseases caused by bacteria. For intravenous and subcutaneous injection in cattle and intramuscular injection in pigs.

Proposed Variation to Conditions:

Peracute/acute mastitis in lactating cows caused by susceptible E. coli.

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; and
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; and
2. where requests for copies of the public information relating to the application can be sent; and
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, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

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 12th day of January 2016.

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