Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 54

6 MARCH 2008


Product:
NovoMix 50 Flexpen
Active Ingredient:
Insulin aspart 100IU/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Product:
NovoMix 50 Penfill
Active Ingredient:
Insulin aspart 100IU/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Product:
NovoMix 70 Flexpen
Active Ingredient:
Insulin aspart 100IU/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Product:
NovoMix 70 Penfill
Active Ingredient:
Insulin aspart 100IU/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturer:
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Product:
Tamsulosin-Rex
Active Ingredient:
Tamsulosin hydrochloride 0.4mg
Dosage Form:
Modified release capsule
New Zealand Sponsor:
REX Medical Limited
Manufacturer:
Cipla Limited, Manufacturing & Research Div., Virgonagar, Old Madras Road, Bangalore, India

Product:
Tisseel Duo 500
Active Ingredients:
Aprotinin 3,000kIU
Factor XIII 10 – 50U in Total Protein Solution
Fibrinogen 70 – 100mg/mL in Total Protein Solution
Plasma protein fraction as Plasma fibronectin 2 – 9mg/mL in Total Protein solution
Plasminogen 40 – 120µg/mL in Total Protein solution
Dosage Form:
Syringe 1 Topical solution
Active Ingredients:
Calcium chloride dihydrate 40µmol/mL
Thrombin 500IU/mL
Dosage Form:
Syringe 2 Topical solution
New Zealand Sponsor:
Baxter Healthcare Limited
Manufacturer:
Baxter AG, Vienna, Austria

Dated this 29th day of February 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).

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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 Milk Teeth
Active Ingredient:
Sodium fluoride 1.17mg/g
Dosage Form:
Toothpaste
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia

Dated this 29th day of February 2008.

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

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2008, No 54


Gazette.govt.nz PDF NZ Gazette 2008, No 54





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
29 February 2008
Medicines Act, New Medicines, NovoMix, Tamsulosin-Rex, Tisseel Duo 500
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Consent to the Distribution of a New Related Product

🏥 Health & Social Welfare
29 February 2008
Medicines Act, New Related Product, Macleans Milk Teeth
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate