I, Shaleen Narayan, Acting Manager Approvals, of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, give notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), that a decision has been made to reassess the following trade name product under section 29 of the Act:
Purpose of Reassessment
The purpose of the reassessment is to re-evaluate the approved dose rate of 13mg pyrantel embonate per kilogram bodyweight (4.6mg pyrantel per kilogram bodyweight) delivered by the trade name product Strategy-T to determine whether the efficacy of the dose is supported.
The trade name product to be reassessed is:
Active Ingredients and Presentation
9.1g pyrantel embonate and 7.0g oxfendazole per 35mL syringe.
The product is to be administered to horses at a dose rate of 5mL paste per 100kg bodyweight, delivering 4.6mg pyrantel base and 10mg oxfendazole per kg bodyweight
Strategy-T is approved for the treatment and control of large strongyles (Strongylus spp., Triodontophorus spp.), small strongyles (Cyanthostomum spp. including benzimidazole-resistant strains), large roundworms (Parascaris equorum including macrocyclic lactone and dual macrocyclic lactone + pyrantel resistant strains), and pinworms (Oxyuris equi) in horses. It is also approved as an aid in control of tapeworm (Anoplocephala perfoliata) in horses.
Further information about the trade name product listed above, including details of their approved uses and target species, can be found on the ACVM Register at https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.
Any person may make a written submission to the director-general concerning this application.
Each submission must state the trade name product(s) to which the submission pertains.
Under sections 16 and 17 of the Act, a written submission:
- must state in full the reasons for making the submission; and
- 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.
If you wish to provide a submission, please email your submission to ACVM.email@example.com. MPI encourages respondents to forward comments by email.
If you wish to forward a submission by post, the following address is:
- where submissions on this application are to be sent; and
- where requests for copies of the public information relating to the application can be sent; and
- where public information relating to the application can be viewed; and
- the director-general’s address for service:
ACVM Programmes and Appraisals, New Zealand Food Safety, Ministry for Primary Industries, PO Box 2526, Wellington 6140.
The applicant’s address for service is:
Virbac New Zealand Limited, 26–30 Maui Street, Pukete Park, Hamilton 3200.
Dated at Wellington this 21st day of October 2020.
SHALEEN NARAYAN, Acting Manager Approvals, Ministry for Primary Industries (acting under delegated authority).