Medicines Act Notices




2178 NEW ZEALAND GAZETTE, No. 84 26 JULY 2007

Medicines Act 1981

Consent to the Distribution of New Medicines

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

Schedule

Product:
DBL® Piperacillin and Tazobactam

Active Ingredients:
Piperacillin 2g
Tazobactam 0.25g

Dosage Form:
Powder for injection

New Zealand Sponsor:
Mayne Pharma (NZ) Limited

Manufacturer:
Orchid Chemicals and Pharmaceuticals Limited, Kancheepuram District, India

Product:
DBL® Piperacillin and Tazobactam

Active Ingredients:
Piperacillin 4g
Tazobactam 0.5g

Dosage Form:
Powder for injection

New Zealand Sponsor:
Mayne Pharma (NZ) Limited

Manufacturer:
Orchid Chemicals and Pharmaceuticals Limited, Kancheepuram District, India

Product:
DBL® Ciprofloxacin Injection for Intravenous Infusion

Active Ingredient:
Ciprofloxacin 2mg/mL

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Mayne Pharma (NZ) Limited

Manufacturer:
Biomendi S.A., Bernedo (Alava), Spain

Product:
Ondansetron Sandoz

Active Ingredient:
Ondansetron hydrochloride dihydrate 2.5mg/mL equivalent to 2mg/mL ondansetron base

Dosage Form:
Solution for injection

New Zealand Sponsor:
Sandoz New Zealand, Novartis New Zealand Limited

Manufacturer:
Pharmathen SA, Pallini, Attikis, Greece

Product:
Orgalutran

Active Ingredient:
Ganirelix 0.5mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Pharmaco (NZ) Limited

Manufacturer:
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Dated this 19th day of July 2007.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of a New Related Product

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 product set out in the Schedule hereto:

Schedule

Product:
Close Up Crystal Blue

Active Ingredients:
Sodium fluoride 0.21%
Triclosan 0.1%

Dosage Form:
Toothpaste

New Zealand Sponsor:
Kenny Marketing Limited

Manufacturer:
Hindustan Lever Limited, Gandhidham, Gujarat, India

Dated this 19th day of July 2007.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2007, No 84


Gazette.govt.nz PDF NZ Gazette 2007, No 84





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
19 July 2007
Medicines, Distribution, Consent, Medicines Act 1981
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Consent to the Distribution of a New Related Product

🏥 Health & Social Welfare
19 July 2007
Medicines, Distribution, Consent, Medicines Act 1981
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Consent to the Distribution of a Changed Medicine

🏥 Health & Social Welfare
19 July 2007
Medicines, Distribution, Consent, Medicines Act 1981
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate