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
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Apo-Rivaroxaban
Rivaroxaban 10mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Apo-Rivaroxaban
Rivaroxaban 15mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Apo-Rivaroxaban
Rivaroxaban 20mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Atazanavir
Atazanavir sulfate 170.872mg equivalent to atazanavir 150mg
Capsule
Teva Pharma (New Zealand) Limited
PLIVA Croatia Limited, Zagreb, Croatia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Atazanavir
Atazanavir sulfate 227.829mg equivalent to atazanavir 200mg
Capsule
Teva Pharma (New Zealand) Limited
PLIVA Croatia Limited, Zagreb, Croatia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Atazanavir
Atazanavir sulfate 341.744mg equivalent to atazanavir 300mg
Capsule
Teva Pharma (New Zealand) Limited
PLIVA Croatia Limited, Zagreb, Croatia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Gamunex
Normal immunoglobulin 100mg/mL
Solution for infusion
Medi’Ray New Zealand Limited
Grifols Therapeutics LLC, North Carolina, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Humira
Adalimumab 100mg/mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
AbbVie Biotechnology Limited, Barceloneta, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Humira Pen
Adalimumab 100mg/mL
Solution for injection
AbbVie Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
AbbVie Biotechnology Limited, Barceloneta, Puerto Rico
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Izba
Travoprost 30mcg/mL
Eye drops, solution
Novartis New Zealand Limited
SA Alcon Couvreur NV, Puurs, Belgium
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Dated this 19th day of March 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz