Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 1699)

Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”) of a decision to reassess the following trade name product(s) under section 29 of the Act.

Purpose of Reassessment

The purpose of the reassessment is to:

Review the chemistry, manufacturing, and anthelmintic active ingredient release or payout profile for all products listed below;
Review the product claims to ensure they are representative of expected product performance and efficacy;
Review the withholding periods applied to each product; and
Review the maximum residue levels for all active ingredients, and amend as needed.

The trade name products to be reassessed are:

Registration Number:	Trade Name:	Active ingredients:	Formulation type:	Use claim:	Registrant & Registrant Address:
A007905	Extender SeCo	Albendazole plus selenium and cobalt	Oral bolus for sheep	For 100 day protection against gastrointestinal parasites. For the reduction in populations of infective parasite larvae on pasture. For the promotion of growth and productivity through the control of infective parasite larvae. For the treatment and prevention of selenium deficiency in sheep for at least 250 days, vitamin B12 deficiency in sheep for 100 days, and the elevation of milk vitamin B12 levels in lactating ewes. For the treatment of ewes 2-6 weeks pre-lambing to protect lambs against selenium deficiency until weaning. As an aid in the control of dags caused by gastrointestinal parasites. As an aid in the reduction of gastrointestinal parasites in lambs prior to weaning.	Argenta Manufacturing Limited PO Box 75340 Manurewa Auckland 2243
A010559	Toby	Abamectin and albendazole, plus selenium and cobalt	Oral bolus for sheep	For the treatment and 100 days protection against sensitive strains or sensitive stages of internal parasites. Treats established and newly ingested internal parasites that are sensitive to either avermectin or benzimidazole families or both. For the reduction in populations of infective parasite larvae on pasture. For the promotion of growth and productivity through the control of internal parasites. Aids in the control of dags and associated flystrike caused by internal parasites that can lead to Flystrike. Aids in the reduction of internal parasites in lambs prior to weaning. For the treatment and prevention of selenium deficiency in sheep for 250 days, cobalt (Vitamin B12) deficiency in sheep for 100 days and for the elevation milk Vitamin B12 levels in lactating ewes. For treatment of ewes pre lambing to protect suckling lambs from selenium deficiency until weaning.	Argenta Manufacturing Limited PO Box 75340 Manurewa Auckland 2243
A011825	Bionic Plus	Abamectin and albendazole, plus selenium and cobalt	Oral bolus for sheep	For the treatment and 100 days protection against sensitive strains or sensitive stages of internal parasites. Treats established and newly ingested internal parasites that are sensitive to either avermectin or benzimidazole families or both. For the reduction in populations of infective parasite larvae on pasture. For the promotion of growth and productivity through the control of internal parasites. Aids in the control of dags and associated flystrike caused by internal parasites that can lead to Flystrike. Aids in the reduction of internal parasites in lambs prior to weaning. For the treatment and prevention of selenium deficiency in sheep for 250 days, cobalt (Vitamin B12) deficiency in sheep for 100 days and for the elevation milk Vitamin B12 levels in lactating ewes. For treatment of ewes pre lambing to protect suckling lambs from selenium deficiency until weaning.	Argenta Manufacturing Limited PO Box 75340 Manurewa Auckland 2243
A009646	Bionic Hi Mineral Combination Sheep Capsules	Abamectin and albendazole, plus selenium and cobalt	Oral bolus for sheep	For the treatment and 100 day control of internal parasites. Aids in the control of dags and associated flystrike caused by gastrointestinal parasites. For the promotion of growth and productivity through the control of gastrointestinal parasites. Reduces pasture contamination with worm eggs for at least 100 days. Aids in the reduction of gastrointestinal parasites prior to weaning in lambs born to treated ewes.	Boehringer Ingelheim Animal Health NZ Ltd PO Box 76211 Manukau City Auckland 2241
A010238	Bionic Hi Mineral Combination Lamb Capsules	Abamectin and albendazole, plus selenium and cobalt	Oral bolus for sheep	For the treatment and 100 day control of internal parasites. Aids in the control of dags and associated flystrike caused by gastrointestinal parasites. For the promotion of growth and productivity through the control of gastrointestinal parasites. Reduces pasture contamination with worm eggs for at least 100 days. Aids in the reduction of gastrointestinal parasites prior to weaning in lambs born to treated ewes.	Boehringer Ingelheim Animal Health NZ Ltd PO Box 76211 Manukau City Auckland 2241
A011000	Bionic Prime	Abamectin, albendazole, and levamisole, plus selenium and cobalt	Oral bolus for sheep	For the treatment and 100 day control of internal parasites. Contains selenium and cobalt. Aids in the control of dags and associated flystrike caused by gastrointestinal parasites. For the promotion of growth and productivity through the control of gastrointestinal parasites. Reduces pasture contamination with worm eggs for at least 100 days. Aids in the reduction of gastrointestinal parasites prior to weaning in lambs born to treated ewes.	Boehringer Ingelheim Animal Health NZ Ltd PO Box 76211 Manukau City Auckland 2241
A011320	Centramax	Abamectin and albendazole, plus selenium and cobalt	Oral bolus for sheep	Protects against internal parasites for 100 days in sheep.	Nexan Corporation PO Box 217234 Botany Junction Auckland 2164
A011121	Alpheus Anti-Parasitic Capsules	Abamectin, oxfendazole, and levamisole	Oral bolus for cattle	Protects against established and incoming parasites for approximately 125 days.	Sirona Animal Health Limited 125A Oceanbeach Road Mount Maunganui 3116

Further information about the trade name products listed above, including details of their approved uses and target species, can be found on the Agricultural Compounds and Veterinary Medicines Register at https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.

Any person may make a written submission to the director-general concerning this reassessment.

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 the reassessment; and
must be received by the director-general no later than 30 working days after the date of this notice.

Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the registrant.

The following address is:

where submissions on this reassessment are to be sent; and
where requests for copies of the public information relating to this reassessment can be sent; and
where public information relating to this reassessment can be viewed; and
the director-general’s address for service:

ACVM Team, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: ACVM.consultation@mpi.govt.nz.

MPI encourages submissions by email.

Dated at Wellington this 24th day of July 2023.

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

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