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
Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Afluria Quad Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15mcg Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 15mcg Influenza virus B/Brisbane/60/2008 - like strain 15mcg Influenza virus B/Phuket/3073/2013 - like strain 15mcg Suspension for injection Seqirus (NZ) Limited Seqirus Pty Limited, Melbourne, Australia
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Noxafil Posaconazole 40mg/mL Oral suspension Merck Sharp & Dohme (New Zealand) Limited Patheon Inc, Whitby, Canada
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Noxafil Posaconazole 100mg Modified release tablet Merck Sharp & Dohme (New Zealand) Limited NV Organon, Oss, Netherlands
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Noxafil Posaconazole 18mg/mL Concentrate for injection Merck Sharp & Dohme (New Zealand) Limited MSD International GmbH, Innishannon, Ireland
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Sporanox Itraconazole 100mg Capsule Janssen-Cilag (New Zealand) Limited Janssen-Cilag SpA, Latina, Italy
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Dated this 7th day of September 2018.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).