Maree Zinzley, Manager (Approvals Operations) of the Ministry of Agriculture and Forestry (MAF) acting under delegated authority from the Director-General of MAF, 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: Rotagal
Reference: A010777
Active Ingredients:
Inactivated bovine rotavirus strain TM-91
Inactivated bovine coronavirus strain C-197
Adheasion F5 (K99) from Escherichia coli strain EC/17
Formulation Type: Oily solution or suspension
General Use Claims:
Active immunisation of healthy pregnant cows and heifers to provide calves with passive immunity targeted at reducing mortality, incidence and severity of diarrhoea from gastrointestinal infections caused by enteropathogenic Escherichia coli, Bovine rotavirus and Bovine coronavirus.
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:
(a) must state in full the reasons for making the submission; and
(b) may state any decision sought on that application; and
(c) 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:
(a) where submissions on this application are to be sent; and
(b) where requests for copies of the public information relating to the application can be sent; and
(c) where public information relating to the application can be viewed; and
(d) the director-general’s address for service:
ACVM Group, Ministry of Agriculture and
Forestry, Pastoral House, Level 11, 25 The
Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
The applicant’s address for service is:
Phoenix Pharm Distributors Limited, 3C Whetu Place, Mairangi Bay, Auckland 0632. Postal Address: PO Box 31363, Milford, Auckland 0741.
Dated at Wellington this 22nd day of February 2012.
MAREE ZINZLEY, Manager (Approvals Operations), Ministry of Agriculture and Forestry (acting under delegated authority).