Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 992)

Publication Date
15 Apr 2019

Tags

Agricultural Compounds and Veterinary Medicines Act Reassessment of registered trade name products Primary Industries

Notice Number

2019-go1654
Title
View PDF
File Type and Size
PDF (33 KB)

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

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:

  1. must state in full the reasons for making the submission; and
  2. may state any decision sought on that application; and
  3. 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:

  1. where submissions on this application are to be sent; and
  2. where requests for copies of the public information relating to the application can be sent; and
  3. where public information relating to the application can be viewed; and
  4. 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).