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 |
|
A001749 |
TETRAVET 100 SOLUBLE ANTIBIOTIC POWDER |
Oxytetracycline Hydrochloride, |
|
A005092 |
DryClox AF |
Ampicillin, Cloxacillin Benzathine, |
|
A005544 |
GENTAVET 100. |
Gentamicin, |
|
A005581 |
BAYTRIL 10% INJECTABLE SOLUTION |
Enrofloxacin, |
|
A005729 |
BAYTRIL 15 |
Enrofloxacin, |
|
A005730 |
BAYTRIL 50 flavour Antibacterial Tablets |
Enrofloxacin, |
|
A005731 |
BAYTRIL 150 flavour Antibacterial Tablets |
Enrofloxacin, |
|
A005732 |
BAYTRIL 2.5% INJECTABLE SOLUTION |
Enrofloxacin, |
|
A005893 |
ERYTHROSOL |
Erythromycin, |
|
A006811 |
DC Xtra AF |
Ampicillin, Cloxacillin Benzathine, |
|
A006892 |
TETRAVET SPRAY |
Gentian Violet, Oxytetracycline Hydrochloride, |
|
A007066 |
TRISULFIN ANTIBACTERIAL BOLUS |
Sulfadiazine, Trimethoprim, |
|
A007453 |
TETRAVET AEROSOL |
Gentian Violet, Oxytetracycline Hydrochloride, |
|
A007485 |
TETRAVET BLUE |
Oxytetracycline Hydrochloride, |
|
A007555 |
TRISULFIN SUSPENSION |
Kaolin, Pectin, Potassium Chloride, Sodium Chloride, Sulfadiazine, Trimethoprim, |
|
A007958 |
BAYTRIL OTIC |
Enrofloxacin, Silver Sulfadiazine, |
|
A009423 |
Penethaject |
Penethamate Hydriodide, |
|
A009626 |
Scourban Plus |
Calcium Gluconate ( Mixture Of Isomers), Glycine, Hyoscine Hydrobromidetri-Hydrate, Kaolin, Magnesium Sulfate, Pectin, Potassium Chloride, Sodium Chloride, Sulfadiazine, Sulphaguanidine, Sulphamethazine, |
|
A009768 |
Lactapen |
Penicillin G Procaine, |
|
A009860 |
Lactapen G |
Penicillin G Procaine, |
|
A009912 |
Lactaclav |
Amoxycillin Present As Amoxycillin Trihydrate, Clavulanic Acid Present As Potassium Clavulanate, Prednisolone, |
|
A010006 |
Tyloject |
Tylosin, |
|
A010050 |
Clavobay LC |
Amoxycillin Present As Amoxycillin Trihydrate, Clavulanic Acid Present As Potassium Clavulanate, |
|
A010064 |
Cepha-Forte DC |
Cephalonium, |
|
A010099 |
Tetravet 100 PVP |
Oxytetracycline Hydrochloride, |
|
A010129 |
Tetravet 100 Flexidose |
Oxytetracycline Hydrochloride, Oxytetracycline Present As Oxytetracycline Hydrochloride, |
|
A010130 |
Tetravet 200 SC |
Oxytetracycline Present As Oxytetracycline Dihydrate, |
|
A010184 |
Ceftiject |
Ceftiofur Present As Ceftiofur Sodium, |
|
A010313 |
Tylosin Base Injection |
Tylosin, |
|
A010314 |
Bomacure |
Cephapirin Benzathine, |
|
A010418 |
Ceftiject RTU |
Ceftiofur Present As Ceftiofur Hydrochloride, |
|
A010504 |
Baytril 25 Flavour Antibacterial Oral Suspension |
Enrofloxacin, |
|
A010610 |
Florfenicol Premix |
Florfenicol, |
|
A010614 |
Procaine Penicillin 30 |
Penicillin G Benzathine, Penicillin G Procaine, |
|
A010697 |
Cefaject |
Ceftiofur, |
|
A010714 |
Tylosin 300 Injection |
Tylosin, |
|
A010772 |
Tylofen |
Ketoprofen, Tylosin, |
|
A010792 |
Ultraclox 24 |
Cloxacillin, |
|
A010920 |
Penethaject RTU |
Penethamate Hydriodide, |
|
A010927 |
Veraflox Tablets for Dogs and Cats |
Pradofloxacin, |
|
A011125 |
Dryclox Xtra |
Ampicillin Trihydrate, Cloxacillin Benzathine, |
|
A011126 |
Dryclox DC |
Ampicillin Trihydrate, Cloxacillin Benzathine, |
|
A011156 |
Veraflox 25 mg/mL Oral Suspension for Cats |
Pradofloxacin, |
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 application.
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:
Bayer New Zealand Limited, PO Box 2825, Shortland Street, Auckland 1140.
Dated at Wellington this 8th day of April 2019.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).