NEW ZEALAND GAZETTE, No. 114

25 SEPTEMBER 2014

Product: APO-Paracetamol XR 665 mg
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rubicon Research Pvt. Limited, Mumbai, India

Product: Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion
Active Ingredient: Clarithromycin 500mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Max Health Limited
Manufacturer: Laboratorios Alcala Farma S.L., Madrid, Spain

Product: Paracetamol XR 665 mg
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rubicon Research Pvt. Limited, Mumbai, India

Product: Riodine Povidone-Iodine Concentrated Gargle
Active Ingredient: Povidone-iodine 75mg/mL equivalent to 0.75% w/v iodine
Dosage Form: Mouthwash
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Perrigo Australia, Balcatta, Australia

Dated this 18th day of September 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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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 393)

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: Fenpral Intestinal Wormer for Dogs
Reference: A11086
Active Ingredients and Concentrations:

• Praziquantel 75.75g/kg
• Pyrantel Embonate 218.82g/kg
• Fenbendazole 378.78g/kg

Formulation Type: Tablet
General Use Claim:
For the control of gastrointestinal worms in dogs.

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;
(b) where requests for copies of the public information relating to the application can be sent;
(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:
John Bates, Robyn Bates Pharmaceuticals, 208 Roslyn Road, Levin 5500.

Dated at Wellington this 18th day of September 2014.

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 394)

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: Alpheus anti-parasitic capsules
Reference: A11121
Active Ingredients and Concentrations:

• Abamectin 150.88g/kg
• Levamisole hydrochloride 312.50g/kg
• Oxfendazole 188.75g/kg

Formulation Type: Tablet