Maree Zinzley, Manager Approvals Operations of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“the Act”), that the following application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: Rotavec Corona

Reference: A8132

Active Ingredients and Concentrations:

Bovine coronavirus (inactivated)
Bovine rotavirus (inactivated)
Escherichia coli K99 (pili)

Formulation Type: Oily solution

General Use Claim:

For the active immunisation of pregnant cows and heifers to raise antibodies against rotavirus, coronavirus and Escherichia coli adhesion F5 (K99) antigen. While the calves are fed colostrum from vaccinated cows during the first two to four weeks of life, these antibodies have been demonstrated to:

• Reduce the incidence of scours caused by rotavirus.
• Reduce the severity of diarrhoea caused by Escherichia coli F5 (K99).
• Reduce the shedding of virus by calves infected with rotavirus or coronavirus.

Intramuscular Injection: Vaccinate in the anterior third of the neck. Do not vaccinate at other intramuscular sites other than the recommended site.

Subcutaneous Injection: Vaccinate in the caudal tail fold (ischiorectal fossa) or in the anterior third of the neck.

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; and
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 notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

The following address is:

1. where submissions on this application are to be sent; and
2. where requests for copies of the public information relating to the application can be sent; and
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Group, Ministry for Primary Industries, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

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

Dated at Wellington this 20th day of October 2015.

MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).