Notice of Reassessment of Registered Trade Name Products (Notice No. MPI ACVM 74)

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 products 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. 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 & Registrant Address:
A005581	Baytril 10% Injectable Solution	Enrofloxacin 100mg/mL	Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104
A005729	Baytril 15	Enrofloxacin 15mg	Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104
A005730	Baytril 50 flavour Antibacterial Tablets	Enrofloxacin 50mg	Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104
A005731	Baytril 150 flavour Antibacterial Tablets	Enrofloxacin 150mg	Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104
A005732	Baytril 2.5% Injectable Solution	Enrofloxacin 25mg/mL	Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104
A010504	Baytril 25 Flavour Antibacterial Oral Suspension	Enrofloxacin 25mg/mL	Elanco New Zealand, 106 Wiri Station Road, Manukau, Auckland 2104
A010358	Enrobactin 150 Antibiotic Tablets	Enrofloxacin 150mg	Dechra Veterinary Products NZ Limited, 198A Kapiti Road, Paraparaumu 5032, Wellington
A010359	Enrobactin 50 Antibiotic Tablets	Enrofloxacin 50mg	Dechra Veterinary Products NZ Limited, 198A Kapiti Road, Paraparaumu 5032, Wellington

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:

must state in full the reasons for making the submission; and
may state any decision sought on the reassessment; and
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:

where submissions on this application are to be sent; and
where requests for copies of the public information relating to the reassessment can be sent; and
where public information relating to this reassessment can be viewed; and
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 11th day of March 2025.

SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI ACVM 74)

Tags

Notice Number

Purpose of Reassessment