✨ Medicines Distribution Consent




5 MARCH 2009 NEW ZEALAND GAZETTE, No. 26 733

Schedule

Product: Januvia
Active Ingredient: Sitagliptin phosphate 128.5mg equivalent to 100mg sitagliptin
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme SpA, Pavia, Italy

Product: Januvia
Active Ingredient: Sitagliptin phosphate 32.13mg equivalent to 25mg sitagliptin
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme SpA, Pavia, Italy

Product: Januvia
Active Ingredient: Sitagliptin phosphate 64.25mg equivalent to 50mg sitagliptin
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme SpA, Pavia, Italy

Dated this 27th day of February 2009.

STUART POWELL, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health
(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: Avamys
Active Ingredient: Fluticasone furoate 27.5ΞΌg
Dosage Form: Nasal spray suspension
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Barnard Castle, Co. Durham, United Kingdom

Product: Hysite
Active Ingredient: Latanoprost 50ΞΌg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Belgium, Puurs, Belgium

Product: Janumet
Active Ingredients:

  • Metformin hydrochloride 1,000mg
  • Sitagliptin phosphate 64.25mg equivalent to 50mg base
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
    Manufacturer: Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico

Product: Janumet
Active Ingredients:

  • Metformin hydrochloride 500mg
  • Sitagliptin phosphate 64.25mg equivalent to 50mg base
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
    Manufacturers: Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico

Product: Janumet
Active Ingredients:

  • Metformin hydrochloride 850mg
  • Sitagliptin phosphate 64.25mg equivalent to 50mg base
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
    Manufacturer: Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 26





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Changed Medicine (continued from previous page)

πŸ₯ Health & Social Welfare
27 February 2009
Medicines Act 1981, Distribution of Medicine, Januvia, Sitagliptin phosphate
  • STUART POWELL, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, Distribution of Medicine, Avamys, Fluticasone furoate, Hysite, Latanoprost, Janumet, Metformin hydrochloride, Sitagliptin phosphate