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 Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Fluarix Tetra Influenza virus A/California/7/2009 (H1N1) like strain 15mcg Influenza virus A/Texas/50/2012 (H3N2) like strain 15mcg Influenza virus B/Massachusetts/2/2012 like strain 15mcg Influenza virus B/Yamagata 16/88 15mcg Suspension for injection GlaxoSmithKline (NZ) Limited GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Biologicals (Dresden), Dresden, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Gazyva Obinutuzumab 1000mg Concentrate for infusion Roche Products (NZ) Limited Roche Diagnostics GmbH, Mannheim, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Risperidone ODT Mylan Risperidone 0.5mg Orodispersible 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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Risperidone ODT Mylan Risperidone 1mg Orodispersible 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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Risperidone ODT Mylan Risperidone 2mg Orodispersible 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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Risperidone ODT Mylan Risperidone 3mg Orodispersible 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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Risperidone ODT Mylan Risperidone 4mg Orodispersible tablet Mylan New Zealand Limited Mylan Laboratories Limited, Maharashtra State, India
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Dated this 6th day of November 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).