Medicines Consent Notices




NEW ZEALAND GAZETTE

No. 78

Health

Medicines Act 1981

Consent to the Distribution of Changed Medicines

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

Schedule

Product:
Engerix-B vaccine

Active Ingredient(s):
Hepatitis B surface antigen (recombinant) 20µg/mL

Dosage Form:
Suspension for injection

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
SmithKline Beecham Biologicals SA, Rixensart, Belgium

Product:
Infanrix-HepB

Active Ingredient(s):
Tetanus toxoid 80IU/mL
Hepatitis B surface antigen (recombinant) 20µg/mL
Diphtheria toxoid (adsorbed) 60IU/mL
Detoxified pertussis toxin 50µg/mL
Pertussis filamentous haemagglutinin 50µg/mL
Pertactin 16µg/mL

Dosage Form:
Suspension for injection

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
SmithKline Beecham Biologicals SA, Rixensart, Belgium

Product:
Twinrix Adult

Active Ingredient(s):
Hepatitis A vaccine 720EU/mL
Hepatitis B surface antigen (recombinant) 20µg/mL

Dosage Form:
Suspension for injection

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
SmithKline Beecham Biologicals SA, Rixensart, Belgium

Product:
Twinrix Junior

Active Ingredient(s):
Hepatitis A vaccine 720EU/mL
Hepatitis B surface antigen (recombinant) 20µg/mL

Dosage Form:
Suspension for injection

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
SmithKline Beecham Biologicals SA, Rixensart, Belgium

Dated this 10th day of July 2000.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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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 medicine set out in the Schedule hereto:

Schedule

Product:
Beta

Active Ingredient(s):
Betamethasone valerate 0.1215%w/w equivalent to betamethasone 0.1%

Dosage Form:
Topical cream

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer(s):
Pacific Pharmaceuticals Limited, Mount Wellington, Auckland
PSM Healthcare Limited, Wiri, Auckland

Product:
Beta

Active Ingredient(s):
Betamethasone valerate 0.1215%w/w equivalent to betamethasone 0.1%

Dosage Form:
Topical ointment

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer(s):
Pacific Pharmaceuticals Limited, Mount Wellington, Auckland
PSM Healthcare Limited, Wiri, Auckland



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 78


Gazette.govt.nz PDF NZ Gazette 2000, No 78





✨ LLM interpretation of page content

🏥 Consent to the Distribution of Changed Medicines

🏥 Health & Social Welfare
10 July 2000
Medicines, Consent, Distribution, Hepatitis B, Vaccines
  • G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
Medicines, Consent, Distribution, Betamethasone