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 |
|
A008234 |
Cephalexin 200 Broadspectrum Antibiotic Tablet for Dogs and Cats |
Cephalexin, |
|
A002777 |
Canaural Compositum Suspension for Treatment of Otitis Externa and Dermatosis |
Framycetin Sulphate, Fucidin, Nystatin, Prednisolone, |
|
A004600 |
Imflamol Gel |
Allantoin, Neomycin Sulphate, Prednisolone, Undecylenic Acid, Vitamin A Palmitate, |
|
A005701 |
Conoptal Viscous Eye Drops |
Fusidic Acid Hemi Hydrate, |
|
A007794 |
Isaderm Carbomer Gel for Dogs |
Betamethasone, Fusidic Acid Hemi Hydrate, |
|
A008235 |
Cephalexin 600 Antibiotic Tablet for Dogs and Cats |
Cephalexin, |
|
A009582 |
Sulpha-T Paste |
Sulphamethazine, Trimethoprim, |
|
A009971 |
Calefur |
Ceftiofur Present As Ceftiofur Sodium, |
|
A010358 |
Apex Enrofloxacin 150 Antibiotic Tablets |
Enrofloxacin, |
|
A010359 |
Apex Enrofloxacin 50 Antibiotic Tablets |
Enrofloxacin, |
|
A010672 |
TMPS Powder |
Sulphamethazine, Trimethoprim, |
|
A011130 |
Apex PMP Ear Suspension for Dogs and Cats |
Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate, |
|
A011216 |
Cephalexin 600 Tablets with Beef Flavouring |
Cephalexin Mono-Hydrate, |
|
A011391 |
Cyclo Spray |
Chlortetracycline Hydrochloride, |
|
A011405 |
Apex Doxy 100 Paste |
Doxycycline Monohydrate, |
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:
Dechra Veterinary Products NZ Limited, 2 Cal Close, Somersby, New South Wales 2250, Australia.
Dated at Wellington this 8th day of April 2019.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).