Notice of Reassessment of Registered Trade Name Products (Notice No. MPI ACVM 42)

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):	Formulation type:	Registrant & Registrant Address:
A06894	Antirobe Capsules 75mg	Clindamycin hydrochloride 75mg	Caspules	Zoetis New Zealand Limited, Level 4, 8 Mahuhu Crescent, Auckland Central, Auckland 1010
A06895	Antirobe Capsules 25mg	Clindamycin hydrochloride 25mg	Capsules	Zoetis New Zealand Limited, Level 4, 8 Mahuhu Crescent, Auckland Central, Auckland 1010
A08150	Antirobe Capsules 150mg	Clindamycin hydrochloride 150mg	Capsules	Zoetis New Zealand Limited, Level 4, 8 Mahuhu Crescent, Auckland Central, Auckland 1010
A11675	Clindene 150 Tablets	Clindamycin hydrochloride 150mg	Tablets	Dechra Veterinary Products NZ Limited, 198A Kapiti Road, Paraparaumu 5032
A11978	Clindene 75 Tablets	Clindamycin hydrochloride 75mg	Tablets	Dechra Veterinary Products NZ Limited, 198A Kapiti Road, Paraparaumu 5032
A11249	Clindacure	Clindamycin 25mg	Oral Solution	Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland

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 that application; 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 application can be sent; and
where public information relating to the application 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 submission by email.

Dated at Wellington this 14th day of October 2024.

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

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