✨ Medicines Consent




NEW ZEALAND GAZETTE, No. 173

16 DECEMBER 2010


Schedule

Product: Janumet
Active Ingredients: Metformin hydrochloride 500mg
Sitagliptin phosphate 64.25mg equivalent to 50mg base, as the monohydrate
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Patheon Puerto Rico Inc., Caguas, Puerto Rico
Patheon Puerto Rico Inc., Manati, Puerto Rico

Product: Janumet
Active Ingredients: Metformin hydrochloride 850mg
Sitagliptin phosphate 64.25mg equivalent to 50mg base, as monohydrate phosphate
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Patheon Puerto Rico Inc., Caguas, Puerto Rico
Patheon Puerto Rico Inc., Manati, Puerto Rico

Product: Janumet
Active Ingredients: Metformin hydrochloride 1000mg
Sitagliptin phosphate 64.25mg equivalent to 50mg base, as monohydrate phosphate
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Patheon Puerto Rico Inc., Caguas, Puerto Rico
Patheon Puerto Rico Inc., Manati, Puerto Rico

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

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: Modavigil
Active Ingredient: Modafinil 100mg
Dosage Form: Tablet
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: Laboratoires Macors, Auxerre, France
Laboratoires Opodex Industrie, Villeneuve la Garenne, France

Dated this 3rd day of December 2010.

JANICE WILSON, Deputy Director-General, Population Health 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: Arrow-Venlafaxine XR
Active Ingredient: Venlafaxine hydrochloride 42.43mg equivalent to venlafaxine 37.5mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Liconsa SA, Guadalajara, Spain



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 173





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
3 December 2010
Medicines, Distribution, Consent, Medicines Act 1981, Janumet, Januvia, Modavigil
  • Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health