Medicine Distribution Consents




16 DECEMBER 2004 NEW ZEALAND GAZETTE, No. 166 4155

Product: Atacand
Active Ingredient: Candesartan cilexetil 4mg
Dosage Form: Tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden

Product: Atacand
Active Ingredient: Candesartan cilexetil 8mg
Dosage Form: Tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden

Product: Femara
Active Ingredient: Letrozole 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

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

Product: Infanrix-Hib vaccine
Active Ingredients: Detoxified pertussis toxin 25µg
Diphtheria toxoid, adsorbed 30IU
Pertactin 8µg
Pertussis filamentous haemagglutinin 25µg
Tetanus toxoid 40IU
Dosage Form: Suspension for injection
Active Ingredient: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10µg
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Product: Mirena
Active Ingredient: Levonorgestrel 52mg
Dosage Form: Intrauterine contraceptive device
New Zealand Sponsor: Schering (NZ) Limited
Manufacturer: Schering Oy, Turku, Finland

Dated this 9th day of December 2004.

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

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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: Tracleer
Active Ingredient: Bosentan 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: St Ives Medical
Manufacturer: Pantheon Inc, Mississauga, Ontario, Canada

Note: This consent is valid for two years from the date of publication of this notice.



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2004, No 166


Gazette.govt.nz PDF NZ Gazette 2004, No 166





✨ LLM interpretation of page content

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

🏥 Health & Social Welfare
9 December 2004
Medicines Act 1981, Distribution Consent, Atacand, Femara, Infanrix, Infanrix-Hib vaccine, Mirena
  • DON MATHESON, Deputy Director-General, Public Health

🏥 Provisional Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
9 December 2004
Medicines Act 1981, Provisional Consent, Tracleer
  • DON MATHESON, Deputy Director-General, Public Health