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 |
|
A000829 |
MASTALONE |
Neomycin Sulphate, Oleandomycin, Oxytetracycline Hydrochloride, Prednisolone, |
|
A000888 |
ORBENIN DRY COW |
Cloxacillin Benzathine, |
|
A001350 |
NEOMIX CONCENTRATE |
Neomycin Sulphate, |
|
A001862 |
TERRAMYCIN PINKEYE POWDER |
Oxytetracycline Hydrochloride, |
|
A002098 |
LINCO-SPECTIN SOLUBLE POWDER |
Lincomycin Hydrochloride, Spectinomycin Sulphate, |
|
A003664 |
ORBENIN LA |
Cloxacillin Sodium (Anhydrous), |
|
A004751 |
ORBENIN EYE OINTMENT |
Cloxacillin Benzathine, |
|
A004925 |
CLAVULOX Palatable Drops |
Amoxycillin Trihydrate, Potassium Clavulanate, |
|
A005722 |
CLAVULOX READY TO USE INJECTION |
Amoxycillin Trihydrate, Potassium Clavulanate, |
|
A005945 |
CLAVULOX LC |
Amoxicillin, Clavulanic Acid, Prednisolone, |
|
A006036 |
ORBENIN ENDURO |
Cloxacillin Benzathine, |
|
A006077 |
VIBRAVET 100 PASTE FOR CATS & DOGS |
Doxycycline, |
|
A006078 |
VIBRAVET 50 TABLETS FOR CATS & DOGS |
Doxycycline, |
|
A006812 |
EXCENEL |
Ceftiofur, |
|
A006893 |
ANTIROBE AQUADROPS |
Clindamycin Hydrochloride, |
|
A006894 |
Antirobe Antibiotic Capsules 75mg |
Clindamycin Hydrochloride, |
|
A006895 |
Antirobe Antibiotic Capsules 25mg |
Clindamycin Hydrochloride, |
|
A006928 |
VIBRAVET 100 TABLETS FOR LARGE DOGS |
Doxycycline, |
|
A007933 |
Aurofac 200G |
Chlortetracycline, |
|
A008139 |
Clavulox Palatable Tablets Broad Spectrum Antibiotic 50mg |
Amoxycillin Trihydrate, Potassium Clavulanate, |
|
A008140 |
Clavulox Palatable Tablets Broad Spectrum Antibiotic 250mg |
Amoxycillin Trihydrate, Potassium Clavulanate, |
|
A008141 |
Clavulox Palatable Tablets Broad Spectrum Antibiotic 500mg |
Amoxycillin Trihydrate, Potassium Clavulanate, |
|
A008150 |
Antirobe Antibiotic Capsules 150mg |
Clindamycin Hydrochloride, |
|
A010032 |
Convenia |
Cefovecin Present As Cefovecin Sodium, |
|
A010150 |
Excede LA Sterile Suspension. |
Ceftiofur, |
|
A010299 |
Simplicef |
Cefpodoxime Proxetil, |
|
A010814 |
Draxxin Injectable Antibiotic Solution |
Tulathromycin, |
|
A011175 |
Cefaclear |
Cephalonium, |
|
A011314 |
Excenel® Flow |
Ceftiofur Present As Ceftiofur Hydrochloride, |
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:
Zoetis New Zealand Limited, PO Box 2094, Shortland Street, Auckland 1140.
Dated at Wellington this 10th day of April 2019.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).