Medicines Distribution Consents




19 OCTOBER 2006 NEW ZEALAND GAZETTE, No. 118

3511

Schedule

Product:
Symbicort 100/6 Turbuhaler

Active Ingredients:
Budesonide 80µg/dose equivalent to 100µg metered dose
Formoterol fumarate 4.5µg/dose equivalent to 6µg metered dose

Dosage Form:
Powder for inhalation

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer:
AstraZeneca AB, Sodertalje, Sweden

Product:
Symbicort 200/6 Turbuhaler

Active Ingredients:
Budesonide 160µg/dose equivalent to 200µg metered dose
Formoterol fumarate 4.5µg/dose equivalent to 6µg metered dose

Dosage Form:
Powder for inhalation

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer:
AstraZeneca AB, Sodertalje, Sweden

Dated this 13th day of October 2006.

DON MATHESON, Deputy Director-General, Public Health (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:
Macleans White & Shine Toothpaste

Active Ingredient:
Sodium fluoride 0.22%w/w

Dosage Form:
Toothpaste

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited

Manufacturer:
GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia

Dated this 13th day of October 2006.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Pan Benzathine Benzylpenicillin

Active Ingredient:
Benzathine benzylpenicillin 900mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited (trading as Healthcare Logistics)

Manufacturer:
Panpharma, Luitre Fougeres, France

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 13th day of October 2006.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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:
Alustal Alternaria extract

Active Ingredients:
Allergen extracts (Alternaria alternata (50%), Alternaria longipes (50%) extracts) 0.1IC/mL

Dosage Form:
Vial 1 Solution for injection

Active Ingredients:
Allergen extracts (Alternaria alternata (50%), Alternaria longipes (50%) extracts) 1IC/mL

Dosage Form:
Vial 2 Solution for injection

Active Ingredients:
Allergen extracts (Alternaria alternata (50%), Alternaria longipes (50%) extracts) 10IC/mL

Dosage Form:
Vial 3 Solution for injection

New Zealand Sponsor:
Ebos Group Limited

Manufacturer:
Stallergenes SA, Antony Cedex, France



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2006, No 118


Gazette.govt.nz PDF NZ Gazette 2006, No 118





✨ LLM interpretation of page content

🏥 Consent to the Distribution of a Changed Medicine (continued from previous page)

🏥 Health & Social Welfare
13 October 2006
Consent, Distribution, Changed Medicine, Medicines Act 1981, Symbicort, Budesonide, Formoterol
  • DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001)

🏥 Consent to the Distribution of a New Related Product

🏥 Health & Social Welfare
13 October 2006
Consent, Distribution, New Related Product, Medicines Act 1981, Macleans Toothpaste, Sodium fluoride
  • DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001)

🏥 Provisional Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
13 October 2006
Provisional Consent, Distribution, New Medicine, Medicines Act 1981, Pan Benzathine Benzylpenicillin
  • DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001)

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
13 October 2006
Consent, Distribution, New Medicines, Medicines Act 1981, Alustal Alternaria extract, Allergen extracts
  • DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001)