Gazette.govt.nzI, 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 |
|
A007862 |
DURODRY |
Cloxacillin Benzathine, |
|
A007922 |
ULTRAPEN LA |
Penicillin G Procaine, |
|
A007940 |
Alamycin LA |
Oxytetracycline Dihydrate, |
|
A007950 |
Betamox LA |
Amoxycillin Trihydrate, |
|
A007951 |
Alamycin 10 |
Oxytetracycline Hydrochloride, |
|
A007973 |
Norocillin |
Penicillin G Procaine, |
|
A008038 |
Cloxamp DC 500 |
Ampicillin Trihydrate, Cloxacillin Benzathine, |
|
A008039 |
Cloxamp DC 600 |
Ampicillin Trihydrate, Cloxacillin Benzathine, |
|
A008041 |
Alamycin LA 300 |
Oxytetracycline Dihydrate, |
|
A008058 |
Norodine 24 |
Sulfadiazine, Trimethoprim, |
|
A008134 |
Alamycin Aerosol |
Oxytetracycline Hydrochloride, |
|
A008146 |
Lactaclox LC |
Cloxacillin Sodium (Anhydrous), Sodium Ampicillin, |
|
A008294 |
Cephalexin Injection |
Cephalexin, |
|
A008295 |
Noroclav Injection |
Amoxicillin, Clavulanic Acid, |
|
A009010 |
Noroclav Tablets |
Amoxycillin Trihydrate, Potassium Clavulanate, |
|
A009020 |
Bovaclox DC Xtra |
Ampicillin Trihydrate, Cloxacillin Benzathine, |
|
A009281 |
Noroclox DC 600 |
Cloxacillin Benzathine, |
|
A009506 |
Clavet LC |
Amoxicillin, Clavulanic Acid, Prednisolone, |
|
A009737 |
Noroclav Tablets 500mg |
Amoxycillin Trihydrate, Potassium Clavulanate, |
|
A011026 |
Norocef RTU |
Ceftiofur Present As Ceftiofur Hydrochloride, |
|
A011173 |
CloxaSeal 600 |
Bismuth Subnitrate, Cloxacillin Benzathine, |
|
A011433 |
Duramast DC 500 |
Ampicillin Trihydrate, Cloxacillin Benzathine, |
|
A011434 |
Duramast DC 600 |
Ampicillin Trihydrate, Cloxacillin Benzathine, |
|
A011435 |
Soloclox DC 600 |
Cloxacillin Benzathine, |
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:
Norbrook NZ Ltd, c/- Norbrook Laboratories Australia PTY Ltd, PO Box 189, Tullamarine, Victoria 3043, Australia.
Dated at Wellington this 8th day of April 2019.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).