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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Arrow - Tranexamic Acid Tranexamic acid 100mg/mL Solution for injection Actavis New Zealand Limited Gland Pharma Limited, Andhara Pradesh, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Giotrif Afatinib dimaleate 29.56mg equivalent to Afatinib 20mg Film coated tablet Boehringer Ingelheim (NZ) Limited Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Giotrif Afatinib dimaleate 44.34mg equivalent to Afatinib 30mg Film coated tablet Boehringer Ingelheim (NZ) Limited Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Giotrif Afatinib dimaleate 59.12mg equivalent to Afatinib 40mg Film coated tablet Boehringer Ingelheim (NZ) Limited Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Giotrif Afatinib dimaleate 73.9mg equivalent to Afatinib 50mg Film coated tablet Boehringer Ingelheim (NZ) Limited Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Harvoni Ledipasvir 90mg Sofosbuvir 400mg Film coated tablet Gilead Sciences (NZ) Gilead Sciences Limited, County Cork, Ireland Patheon Inc, Ontario, Canada
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Product: Active Ingredient: Dosage Form: New ZealandSponsor: Manufacturer:
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Montelukast Mylan Montelukast sodium 4.15mg equivalent to Montelukast 4mg Chewable tablet Mylan New Zealand Limited Mylan Laboratories Limited, Maharashtra State, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Montelukast Mylan Montelukast sodium 5.19mg equivalent to Montelukast 5mg Chewable tablet Mylan New Zealand Limited Mylan Laboratories Limited, Maharashtra State, India
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Dated this 31st day of October 2014.
SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).