Medicine Distribution Consents




5 FEBRUARY NEW ZEALAND GAZETTE

267

Product: Eloxatin
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer: Laboratoires Thissen SA, Braine-L’Alleud, Belgium

Dated this 2nd day of February 2004.

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

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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: Gutron
Active Ingredient: Midodrine hydrochloride 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Nycomed Austria GmbH, Linz, Austria

Note: This consent is valid for two years from 20 April 2004.

Product: Gutron
Active Ingredient: Midodrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Nycomed Austria GmbH, Linz, Austria

Note: This consent is valid for two years from 20 April 2004.

Dated this 2nd day of February 2004.

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

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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: Depo-Provera
Active Ingredient: Medroxyprogesterone acetate 150mg/mL
Dosage Form: Injection (depot)
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pharmacia NV/SA, Rijksweg 12, Puurs, Belgium

Product: Infanrix
Active Ingredients:

  • Detoxified pertussis toxin 25µg
  • Diphtheria toxoid, adsorbed 30IU
  • Pertactin 8µg
  • Pertussis filamentous haemagglutinin 25µg
  • Tetanus toxoid, adsorbed 40IU
    Dosage Form: Suspension for injection
    New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
    Manufacturers:
  • GlaxoSmithKline Biologicals, Rixensart, Belgium
  • Sachsisches Serumwerk Dresden, Dresden, Germany

Product: Infanrix-HepB
Active Ingredients:

  • Detoxified pertussis toxin 50µg/mL
  • Diphtheria toxoid, adsorbed 60IU/mL
  • Hepatitis B surface antigen, recombinant 20µg/mL
  • Pertactin 16µg/mL
  • Pertussis filamentous haemagglutinin 50µg/mL
  • Tetanus toxoid 80IU/mL
    Dosage Form: Suspension for injection
    New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
    Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium


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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2004, No 11


Gazette.govt.nz PDF NZ Gazette 2004, No 11





✨ LLM interpretation of page content

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

🏥 Health & Social Welfare
2 February 2004
Medicines Act 1981, Distribution, New Medicine, Eloxatin, Oxaliplatin
  • DON MATHESON, Deputy Director-General, Public Health

🏥 Renewal of Provisional Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
2 February 2004
Medicines Act 1981, Provisional Consent, Gutron, Midodrine hydrochloride
  • DON MATHESON, Deputy Director-General, Public Health

🏥 Consent to the Distribution of Changed Medicines

🏥 Health & Social Welfare
2 February 2004
Medicines Act 1981, Distribution, Changed Medicines, Depo-Provera, Infanrix, Infanrix-HepB
  • DON MATHESON, Deputy Director-General, Public Health