Notice of Reassessment of Registered Trade Name Products (Notice No. MPI ACVM 101)
Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”) of a decision to reassess the following trade name product(s) under section 29 of the Act.
The purpose of the reassessment is to re-evaluate the approved label information, use patterns, and regulatory controls for the trade name products named below to ensure these details are consistent with the principles of prudent use for antibiotics and the prevention of antimicrobial resistance. For the product approved for use in food-producing species, the New Zealand maximum residue levels (MRLs) associated with the active ingredient, and the products’ withholding periods, will also be re-evaluated during the reassessment.
The trade name products to be reassessed are:
|
Registration Number: |
Trade Name: |
Active ingredient(s) and its concentration(s): |
Registrant and Registrant Address: |
|
A003322 |
Cepravin Dry Cow |
Cefalonium 250mg/syringe |
Schering Plough Animal Health Ltd, 33 Whakatiki Street, Upper Hutt 5018. |
|
A010064 |
Cepha-Forte DC |
Cefalonium 250mg/syringe |
Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104. |
|
A010107 |
Quadrant DC |
Cefalonium 250mg/syringe |
Virbac New Zealand Limited, 26–30 Maui Street, Pukete, Hamilton 3200. |
|
A011751 |
Ceprotect DC |
Cefalonium 250mg/syringe |
Norbrook NZ Limited, KPMG Centre 18 Viaduct Harbour Avenue, Auckland 1010. |
|
A012049 |
CepraGold |
Cefalonium 250mg/syringe |
Agrihealth NZ Limited, 89 Grafton Road, Grafton, Auckland 1010. |
Further information about the trade name products listed above, including details of their approved uses and target species, can be found on the Agricultural Compounds and Veterinary Medicines Register at https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.
Any person may make a written submission to the Director-General concerning this reassessment. Under sections 16 and 17 of the Act a written submission:
Under sections 16 and 17 of the Act, a written submission:
Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.
If you wish to provide a submission, please email your submission to ACVM.consultation@mpi.govt.nz. MPI encourages respondents to forward comments by email.
If you wish to forward a submission by post, the following address is:
ACVM Programmes and Appraisals, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
MPI encourages submissions by email.
Dated at Wellington this 29th day of October 2025.
SHALEEN NARAYAN, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).