Notice of Application to Register a Trade Name Product (Notice No. MPI 1759)
Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to register a trade name product under section 9(1) of the Act:
Trade Name: CosACTHen 0.25mg/mL Solution for Injection for Dogs
Registration Number: A011944
Active Ingredient and Concentration:
0.25mg/mL Tetracosactide (as the hexaacetate)
Formulation Type: Aqueous Solution
Application method/administration route:
Administer 5µg/kg (0.02mL/kg) by intravenous or intramuscular injection, with the purpose of performing the ACTH stimulation test. Take the first blood sample immediately prior to administering the product and take the second blood sample between 60 and 90 minutes after administration of the product, to assess the cortical response.
Use Claim:
For the evaluation of adrenocortical function in dogs
Any person may make a written submission to the director-general concerning this application.
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 applicant.
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 submission by email.
The applicant’s address for service is:
Dechra Veterinary Products NZ Limited, 198A Kapiti Road, Paraparaumu 5032. Postal Address: 2 Cal Close, Somersby, New South Wales 2250, Australia.
Dated at Wellington this 8th day of November 2023.
MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).