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:
- 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 registrant for the registrant’s information.
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 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).