Notice Type
Departmental
Notice Title

Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI 944)*

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 register a trade name product under section 9(2) of the Act:

Trade Name: Switch Fluke 10

Reference: A011138-04

Active Ingredients and Concentrations:

Abamectin 2g/L

Levamisole HCl 80g/L

Triclabendazole 120g/L

Formulation Type: Aqueous suspension

Current Claims:

For the treatment and control of roundworms and lungworms sensitive to abamectin and/or levamisole (including those resistant to avermectin/milbemycin, benzimidazole or levamisole/morantel or a combination of avermectin/milbemycin with benzimidazole or benzimidazole and levamisole/morantel families) in cattle and sheep. For the treatment and control of triclabendazole-sensitive early immature, immature and mature liver fluke (Fasciola hepatica) in cattle.

Proposed new claims (changes in bold):

For the treatment and control of roundworms and lungworms sensitive to abamectin and/or levamisole (including those resistant to avermectin/milbemycin, benzimidazole or levamisole/morantel or a combination of avermectin/milbemycin with benzimidazole or benzimidazole and levamisole/morantel families) in cattle and sheep. For the treatment and control of triclabendazole-sensitive early immature, immature and mature liver fluke (Fasciola hepatica) in cattle and sheep.

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, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Boehringer Ingelheim Animal Health New Zealand Limited, Level 3, 2 Osterley Way, Manukau, Auckland. Postal Address: PO Box 76211, Manukau, Auckland.

Dated at Wellington this 20th day of November 2018.

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

*This Gazette notice revokes and replaces Notice No. MPI 941, https://gazette.govt.nz/notice/id/2018-go5862 which notified this Trade Name Product as a new product and not a variation to a current product.