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 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
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Dificid
Fidaxomicin 200mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Patheon Inc, Ontario, Canada
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Opdivo
Nivolumab 47mg equivalent to 40mg/4mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Opdivo
Nivolumab 107mg equivalent to 100mg/10mL
Concentrate for infusion
Bristol-Myers Squibb (NZ) Limited
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Sandomigran
Pizotifen malate 0.725mg equivalent to Pizotifen 0.5mg
Tablet
AFT Pharmaceuticals Limited
Labiana Pharmaceuticals SL, Barcelona, Spain
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Soothers - Honey and Lemon
Eucalyptus oil 0.7mg
Menthol 7mg
Sodium ascorbate 11.25mg equivalent to 10mg ascorbic acid
Lozenge
Nestle New Zealand Limited
Nestle Australia Limited, Blacktown, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Winglore (50mg/10mL)
Ipilimumab 5mg/mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Winglore (200mg/40mL)
Ipilimumab 5mg/mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Yervoy (50mg/10mL)
Ipilimumab 5mg/mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Yervoy (200mg/40mL)
Ipilimumab 5mg/mL
Concentrate for injection
Bristol-Myers Squibb (NZ) Limited
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
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Dated this 3rd day of May 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz