Notice Title

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.

Purpose of Reassessment

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:

  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 this notice.

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:

  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 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).