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
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Product:
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New Zealand Sponsor:
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Imodium Zapid (General sale)
Loperamide hydrochloride 2mg
Orodispersible tablet
Johnson & Johnson (New Zealand) Limited
Catalent UK Swindon Zydis Limited, Swindon, United Kingdom
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Product:
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Imodium Zapid (Pharmacy only)
Loperamide hydrochloride 2mg
Orodispersible tablet
Johnson & Johnson (New Zealand) Limited
Catalent UK Swindon Zydis Limited, Swindon, United Kingdom
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Product:
Active Ingredients:
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New Zealand Sponsor:
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Movicol Lemon-Lime Flavour
Macrogol 3350 13.125g
Potassium chloride 46.6mg
Sodium bicarbonate 178.5mg
Sodium chloride 350.7mg
Powder for oral solution
CARSL Consulting
Norgine (UK) Limited, Hengoed, United Kingdom
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Product:
Active Ingredient:
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New Zealand Sponsor:
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Nicorette QuickMist
Nicotine 13.6mg/mL
Oral spray
Johnson & Johnson (New Zealand) Limited
McNeil AB, Helsingborg, Sweden
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Product:
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New Zealand Sponsor:
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Oxis Turbuhaler
Formoterol fumarate 4.5mcg/dose for the M3 device
equivalent to 6mcg/dose of the M2 device
Powder for inhalation
AstraZeneca Limited
AstraZeneca AB, Sodertalje, Sweden
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Dated this 16th day of July 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