NEW ZEALAND GAZETTE, No. 26

1 MARCH 2012

Departmental Notices

Agriculture and Forestry

Agricultural Compounds and Veterinary Medicines Act 1997

Notice of Application to Register a Trade Name Product (Notice No. 1782)

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 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).

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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.

Notice of Application to Register a Trade Name Product (Notice No. 1783)

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: Tylofen
Reference: A010772
Active Ingredients and Concentrations:

• Contains:
  • Tylosin base 200mg
  • Ketoprofen 60mg

Formulation Type: Injectable solution
General Use Claims:
Indicated in the treatment of systemic infections caused by bacteria sensitive to tylosin, and ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic effects.

Indicated for the treatment of infections caused by tylosin-sensitive organisms in cattle where an adjunct therapy with an NSAID is indicated.

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
ACVM Group, Ministry of Agriculture and Forestry, Pastoral House, Level 11, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.