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: 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).