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: Marbocyl P

Reference: A011316

Active Ingredient and Concentrations:

Tablets contain 5mg, 20mg and 80mg marbofloxacin

Formulation Type: Oral tablet

General Use Claim:

For oral administration.
The recommended dose rate is 2mg/kg/d (1 tablet for 10kg per day) in single daily administration. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Dogs
In skin and soft tissue infections, treatment duration is at least five days. Depending on the course of the disease, it may be extended up to 40 days.
In urinary tract infections, treatment duration is at least ten days. Depending on the course of the disease, it may be extended up to 28 days.
In respiratory infections, treatment duration is at least seven days, and depending on the course of the disease it may be extended up to 21 days.

Cats (5mg tablet)
For skin and soft tissue infections (wounds, abscesses, phlegmons) treatment duration is three to five days.
For upper respiratory infections treatment duration is five days.

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:

Ethical Agents Veterinary Marketing Limited, 54 Hobill Avenue, Wiri, Auckland 2104. Postal Address: PO Box 97110, Auckland 2241.

Dated at Wellington this 5th day of April 2016.

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