Notice Title

Notice of Application to Register a Trade Name Product (Notice No. MPI ACVM 55)

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: Bovilis Cryptium

Reference: A012159

Active Ingredients and Concentrations:

An off-white liquid emulsion vaccine containing purified Cryptosporidium parvum glycoprotein 40 adjuvanted with mineral oil and aluminium hydroxide

Formulation Type: Oily suspension

Application Method/ Administration Route: By subcutaneous injection in the anterior third of the neck

Use Claim:

For active immunisation of pregnant heifers and cows to raise antibodies in their colostrum against Gp40 of Cryptosporidium parvum, intended for passive immunisation of calves to reduce clinical signs (i.e. diarrhoea, morbidity and mortality) caused by C. parvum

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:

  1. must state in full the reasons for making the submission;
  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 applicant.

The following address is:

  1. where submissions on this application are to be sent;
  2. where requests for copies of the public information relating to the application can be sent;
  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 submission by email.

The applicant’s address for service is:

Schering-Plough Animal Health Limited, 33 Whakatiki Street, Upper Hutt 5018. Postal Address: Schering-Plough Animal Health Limited, Private Bag 908, Upper Hutt 5140.

Dated at Wellington this 10th day of December 2024.

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