Notice of Reassessment of Registered Trade Name Pradofloxacin Products (Notice No. MPI ACVM 65)
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.
The trade name products to be reassessed are:
Registration Number: |
Trade Name: |
Active ingredient(s) and its concentration(s): |
Registrant and Registrant Address: |
A010927 |
Veraflox Tablets for Dogs and Cats |
Pradofloxacin 15mg |
Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104 |
A011156 |
Veraflox 25mg/mL Oral Suspension for Cats |
Pradofloxacin 25mg/mL |
Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104 |
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:
Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the registrant.
The following address is:
ACVM Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.
MPI encourages submissions by email.
Dated at Wellington this 30th day of January 2025.
SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).