Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 1009)

I, Maree Zinzley, Manager Approvals Operations, 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 products under section 29 of the Act.

Purpose of Reassessment

The reassessment of the trade name products listed below are to establish whether a condition should be imposed on the registration of each of the trade name products listed below. Those trade name products are all antibiotics. The proposed condition would prohibit the advertising of the trade name product, being an antibiotic, to the end-users.

The Trade Name Products to be Reassessed are:

Reference

Trade Name

Active ingredients and concentrations

A003144

VIBROSTREP

Dihydrostreptomycin Sulphate, Streptomycin Sulphate,

A004730

AMPHOPRIM INJECTION

Sulphamethazine, Trimethoprim,

A004807

AMPHOPRIM BOLUS

Sulphamethoxypyridazine, Trimethoprim,

A005108

CLOXAGEL 1000 DC

Cloxacillin Benzathine, Cloxacillin Sodium Monohydrate,

A005301

INTRACILLIN 300 Injection

Penicillin G Procaine,

A006115

AEROTET FORTE

Gentian Violet, Oxytetracycline Hydrochloride,

A006307

OXYFOAM FORTE

Oxytetracycline Hydrochloride,

A006308

INTRACILLIN LA

Penicillin G Benzathine, Penicillin G Procaine,

A006389

TETRAGUARD LA

Oxytetracycline Dihydrate,

A006863

FOUNDERGUARD

Virginiamycin,

A007186

BOVIPEN

Penicillin G Procaine,

A007187

OVIPEN

Penicillin G Benzathine, Penicillin G Procaine,

A007518

INTRACILLIN HIGH POTENCY 500

Penicillin G Procaine,

A007662

RILEXINE 200 LC

Cephalexin,

A007787

INTRACILLIN 1000 MILKING COW

Penicillin G Procaine,

A008037

Masticillin

Penicillin G Procaine,

A009159

Rilexine Palatable Tablets

Cephalexin Mono-Hydrate,

A009341

Mastiguard Milking Cow.

Oleandomycin, Oxytetracycline Hydrochloride,

A009713

Tyloguard

Tylosin,

A009978

Cefaguard

Ceftiofur Present As Ceftiofur Hydrochloride,

A010107

Quadrant DC

Cephalonium,

A010279

Nitroclox LA

Cloxacillin Sodium Monohydrate,

A010305

Easotic

Gentamycin Sulphate, Hydrocortisone Aceponate, Miconazole Nitrate,

A010361

METRI-CLEAN

Cephapirin Benzathine,

A010884

PenClox 1200

Cloxacillin Sodium Monohydrate, Penicillin G Procaine,

Further information about each of the trade name products listed above, including its intended use, can be found on the ACVM Register that is available on MPI’s website: https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.

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

Each submission must state the trade name product(s) the submission pertains to.

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 registrant for the registrant’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, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The registrant’s address for service is:

Virbac New Zealand Ltd, PO Box 10305, Te Rapa, Hamilton 3241.

Dated at Wellington this 10th day of April 2019.

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