Medicines Distribution Consents




NEW ZEALAND GAZETTE, No. 64

27 MARCH 2008

Schedule

Product:
Imigran Recovery

Active Ingredient:
Sumatriptan succinate 70mg equivalent to sumatriptan base 50mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited

Manufacturer:
Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom

Product:
Luxyal Monodose

Active Ingredient:
Sodium hyaluronate 1.5mg/mL

Dosage Form:
Eye drops, solution

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Pharma Stulln GmbH, Stulln, Germany

Product:
Luxyal

Active Ingredient:
Sodium hyaluronate 1.5mg/mL

Dosage Form:
Eye drops, solution

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Tubilux Pharma SpA, Pomezia, Rome, Italy

Product:
Nicotinell TTS 10

Active Ingredient:
Nicotine 17.5mg (7mg/24hr)

Dosage Form:
Transdermal patch

New Zealand Sponsor:
Novartis Consumer Health Australasia Pty Limited (New Zealand)

Manufacturer:
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product:
Nicotinell TTS 20

Active Ingredient:
Nicotine 35mg (14mg/24h)

Dosage Form:
Transdermal patch

New Zealand Sponsor:
Novartis Consumer Health Australasia Pty Limited (New Zealand)

Manufacturer:
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product:
Nicotinell TTS 30

Active Ingredient:
Nicotine 52.5mg (21mg/24h)

Dosage Form:
Transdermal patch

New Zealand Sponsor:
Novartis Consumer Health Australasia Pty Limited (New Zealand)

Manufacturer:
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Dated this 20th day of March 2008.

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

go2047

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:
Colgate Max White - Crystal Mint

Active Ingredient:
Sodium fluoride 0.22% w/w

Dosage Form:
Toothpaste

New Zealand Sponsor:
Colgate-Palmolive Limited

Manufacturers:
Colgate-Palmolive Indústria e Comércio LIMITEDA, Osasco, São Paulo, Brazil
Colgate-Palmolive Indústria e Comércio LIMITEDA, São Bernado do Campo, São Paulo, Brazil

Dated this 20th day of March 2008.

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

go2048

Renewal of Provisional Consent to the Distribution of New Medicines

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 medicines set out in the Schedule hereto:



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2008, No 64


Gazette.govt.nz PDF NZ Gazette 2008, No 64





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
20 March 2008
Medicines Act 1981, New Medicines, Distribution, Schedule
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Consent to the Distribution of a New Related Product

🏥 Health & Social Welfare
20 March 2008
Medicines Act 1981, New Related Product, Distribution, Toothpaste
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Renewal of Provisional Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
Medicines Act 1981, Provisional Consent, Distribution, New Medicines