19 JULY 2012 NEW ZEALAND GAZETTE, No. 86 2373

Product: Zypine® ODT
Active Ingredient: Olanzapine 5mg
Dosage Form: Wafer
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India

Product: Zypine® ODT
Active Ingredient: Olanzapine 10mg
Dosage Form: Wafer
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India

Dated this 11th day of July 2012.

DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Primary Industries

Agricultural Compounds and Veterinary Medicines Act 1997

Notice of Application to Register a Trade Name Product (Notice No. MPI 38)

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 of the Agricultural Compounds and Veterinary Medicines Act 1997 (“the Act”), that the following application has been made to vary a condition on a registered trade name product under section 9(2) of the Act:

Trade Name: Comfortis
Reference: A010118
Active Ingredient and Concentration: Spinosad 533.3g/kg
Formulation Type: Tablet
General Use Claim: For the treatment, prevention and control of flea infestations and for the control of flea allergy dermatitis in cats.

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

The applicant’s address for service is:

Elanco Animal Health, Level 1, 123 Ormiston Road, Flat Bush, Auckland 2016. Postal Address: PO Box 259354, Botany, Auckland 2163.

Dated at Wellington this 13th day of July 2012.

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

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Notice of Application to Register a Trade Name Product (Notice No. MPI 40)

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: Doramectin + Clorsulon Injection
Reference: A010802
Active Ingredients and Concentrations:

• Doramectin 10mg
• Clorsulon 100mg
  Formulation Type: Oily solution/suspension
  General Use Claim: For the treatment and control of doramectin-sensitive and clorsulon-sensitive internal parasites in cattle.

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