1776 NEW ZEALAND GAZETTE, No. 61 3 JUNE 2010

Product: Omezol IV
Active Ingredient: Omeprazole 40mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Sirton Pharmaceuticals S.p.A., Villa Guardia, Italy

Product: Paclitaxel
Active Ingredient: Paclitaxel 6mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Oncotec Pharma Produktion GmbH, Dessau, Germany

Product: Pethidine Injection BP
Active Ingredient: Pethidine hydrochloride 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Macarthys Laboratories Limited t/a Martindale Pharmaceuticals, Romford, United Kingdom

Dated this 26th day of May 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of New Related Products

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new related products set out in the Schedule hereto:

Schedule

Product: Macleans Protect Fresh Mint
Active Ingredient: Sodium fluoride 0.3152%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Ermington, Australia

Product: Macleans Protect Mild Mint
Active Ingredient: Sodium fluoride 0.3152%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Ermington, Australia

Dated this 26th day of May 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines subject to the following amended conditions set out in the Schedule hereto:

Schedule

Product: Clopine
Active Ingredient: Clozapine 50mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand

Note: This consent is given subject to the following conditions:

1. The medicine may only be prescribed by:
   • Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.
   • Medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of the persons referred to above.
   • Medical officers of special scale who:
     – work solely in the field of psychiatry;
     – are in the employment of a district health board; and
     – are under the supervision of persons who are registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.