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
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Akynzeo
Palonosetron hydrochloride 0.56mg
equivalent to palonosetron 0.5mg
Netupitant 300mg
Combination capsule
Mundipharma New Zealand Limited
Helsinn Birex Pharmaceuticals Limited, Dublin, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Bosentan Dr Reddy’s
Bosentan monohydrate 64.541mg
equivalent to bosentan 62.5mg
Film coated tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Bachupally, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Bosentan Dr Reddy’s
Bosentan monohydrate 129.082mg
equivalent to bosentan 125mg
Film coated tablet
Dr Reddy’s New Zealand Limited
Dr Reddy’s Laboratories Limited, Bachupally, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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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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Dated this 3rd day of July 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz