Medicines Distribution Notices




10 JANUARY 2008 NEW ZEALAND GAZETTE, No. 1

31

Schedule

Product: Aclasta
Active Ingredient: Zoledronic acid 0.05mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Botox
Active Ingredient: Botulinum A toxin 100U
Dosage Form: Powder for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, Westport, County Mayo, Ireland

Dated this 7th day of January 2008.

LES STEPHENS, 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 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 medicines set out in the Schedule hereto:

Schedule

Product: ADT Booster
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Tetanus toxoid, adsorbed 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: Statens Serum Institut, Copenhagen, Denmark

Product: Rasilez
Active Ingredient: Aliskiren hemifumarate 165.75mg equivalent to 150mg aliskiren
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Rasilez
Active Ingredient: Aliskiren hemifumarate 331.5mg equivalent to 300mg aliskiren
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Wilate
Active Ingredients: Factor VIII, human 450IU
von Willebrand’s factor: Ristocetin cofactor 400IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Octapharma Pharmazeutika Productionsges, Vienna, Austria

Product: Wilate
Active Ingredients: Factor VIII, human 900IU
von Willebrand’s factor: Ristocetin cofactor 800IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Octapharma Pharmazeutika Productionsges, Vienna, Austria

Dated this 7th day of January 2008.

LES STEPHENS, 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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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:



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2008, No 1


Gazette.govt.nz PDF NZ Gazette 2008, No 1





✨ LLM interpretation of page content

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

🏥 Health & Social Welfare
7 January 2008
Medicines, Distribution, Consent, Aclasta, Botox
  • LES STEPHENS, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
7 January 2008
Medicines, Distribution, Consent, ADT Booster, Rasilez, Wilate
  • LES STEPHENS, Acting Deputy Director-General, Sector Accountability and Funding Directorate

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

🏥 Health & Social Welfare
Medicines, Distribution, Provisional Consent