✨ Medicine Distribution Consents




116 NEW ZEALAND GAZETTE No. 4

NZ Sponsor:

Schering-Plough Pty Limited

Manufacturer(s):

Schering-Plough Limited, Singapore

Product:
Asmanex Twisthaler
Active Ingredient(s):
Mometasone furoate 400Β΅g/dose
Dosage Form:
Powder for inhalation

NZ Sponsor:

Schering-Plough Pty Limited

Manufacturer(s):

Schering-Plough Limited, Singapore

Product:
Clomhexal
Active Ingredient(s):
Clomiphene citrate 50mg
Dosage Form:
Tablet

NZ Sponsor:

Hexal New Zealand Limited

Manufacturer(s):

Heumann Pharma GmbH (Manufacturing Facility), Plant II, Feucht, Germany
Salutas Pharma GmbH, Barleben, Germany

Product:
Zolaten
Active Ingredient(s):
Aciclovir 5% w/w
Dosage Form:
Topical cream

NZ Sponsor:

Pharmaco (NZ) Limited

Manufacturer(s):

Chefaro International BV, Rotterdam, The Netherlands

Dated this 12th day of January 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 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:
Ervevax vaccine
Active Ingredient(s):
Rubella virus (Wistar RA27/3 strain) 1,000TCID50
Dosage Form:
Powder for injection

NZ Sponsor:

SmithKline Beecham (NZ) Limited

Manufacturer(s):

SmithKline Beecham Biologicals SA, Rixensart, Belgium

Product:
Priorix
Active Ingredient(s):
Rubella virus (Wistar RA27/3 strain) 1,000CCID50
Measles vaccine (Schwarz strain) 1,000CCID50
Mumps virus, live attenuated (RIT 4385) 5,012CCID50
Dosage Form:
Powder for injection

NZ Sponsor:

SmithKline Beecham (NZ) Limited

Manufacturer(s):**

Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany
SmithKline Beecham Biologicals SA, Rixensart, Belgium
SmithKline Beecham Biologicals SA, Genval, Belgium

Product:
Rimevax
Active Ingredient(s):
Measles vaccine (Schwarz strain) 1,000TCID50
Dosage Form:
Powder for injection

NZ Sponsor:

SmithKline Beecham (NZ) Limited

Manufacturer(s):**

SmithKline Beecham Biologicals SA, Rixensart, Belgium

Dated this 12th day of January 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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Renewal of 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:
Viracept
Active Ingredient(s):
Nelfinavir mesylate 58.5mg/g equivalent to 50mg/g nelfinavir free base
Dosage Form:
Powder for oral solution

NZ Sponsor:

Roche Products (New Zealand) Limited



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 4


Gazette.govt.nz PDF NZ Gazette 2000, No 4





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
12 January 2000
Medicines Act, New medicine distribution, Asmanex Twisthaler, Mometasone furoate, Clomhexal, Clomiphene citrate, Zolaten, Aciclovir
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
12 January 2000
Medicines Act, Changed medicine distribution, Ervevax vaccine, Rubella virus, Priorix, Measles vaccine, Mumps virus, Rimevax
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
12 January 2000
Medicines Act, Provisional consent renewal, Viracept, Nelfinavir mesylate
  • G. R. Boyd, Chief Advisor, Safety and Regulation