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

Trade Names:

Cytopoint 10mg
Cytopoint 20mg
Cytopoint 30mg
Cytopoint 40mg

References:

A11348-06
A11443-06
A11444-06
A11445-06

Active Ingredients and Concentrations:

A11348 - Lokivetmab 10mg/mL
A11443 - Lokivetmab 20mg/mL
A11444 - Lokivetmab 30mg/mL
A11445 - Lokivetmab 40mg/mL

Formulation Type: Aqueous Solution

Current Claim:

For the treatment of clinical manifestations of atopic dermatitis in dogs

Proposed New Claim (changes in bold):

For the treatment of clinical manifestations of atopic dermatitis and the treatment of pruritus associated with allergic dermatitis in dogs

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.

The applicant’s address for service is:

Zoetis New Zealand Limited, Level 4, 8 Mahuhu Crescent, Auckland Central, Auckland 1010. Postal Address: PO Box 2094, Shortland Street, Auckland 1140.

Dated at Wellington this 11th day of March 2021.

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