Notice of Application to Register a Trade Name Product (Notice No. MPI ACVM 50)
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: Eurican C3
Reference: A012156
Active Ingredients and Concentrations:
Each 1mL dose contains:
Lyophilisate: | Minimum | Maximum |
Attenuated canine distemper virus, strain BA5 | 104.0 CCID50 | 106.0 CCID50 |
Attenuated canine adenovirus type 2, strain DK13 | 102.5 CCID50 | 106.3 CCID50 |
Attenuated canine parvovirus type 2, strain CAG2 | 104.9 CCID50 | 107.1 CCID50 |
Formulation Type: Lyophilisate with aqueous diluent
Application method/ administration route: Subcutaneous injection.
Use Claim:
For active immunisation of dogs to:
Onset of immunity: 2 weeks after the second injection of the primary vaccination course for all strains.
Duration of immunity: at least one year after the second injection of the primary vaccination course for all strains. Challenge and serology data obtained two years after primary vaccination and first annual booster, demonstrated persistent protection against parvovirus, distemper virus and adenovirus for at least two years.
*Protection has been demonstrated against canine parvovirus type 2a, 2b and 2c.
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: Boehringer Ingelheim Animal Health New Zealand Limited, Level 2, 3 Te Kehu Way, Mount Wellington, Auckland 1060. Postal Address: PO Box 76211, Manukau, Auckland 2241.
Dated at Wellington this 22nd day of November 2024.
SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).