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:
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New Zealand Sponsor:
Manufacturer:
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Blackmores Macu-Vision
Ascorbic acid 250mg
Cupric oxide 1.25mg equivalent to copper 1mg
D-alpha-Tocopheryl acid succinate 165mg equivalent to vitamin E 200IU
Zinc oxide 49.8mg equivalent to zinc 40mg
Film coated tablet
Blackmores (NZ) Limited
Catalent Australia Pty Limited, Melbourne, Australia
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Product:
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Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Descovy 200mg/10mg
Emtricitabine 200mg
Tenofovir alafenamide fumarate 11.2mg equivalent to tenofovir alafenamide 10mg
Tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Descovy 200mg/25mg
Emtricitabine 200mg
Tenofovir alafenamide fumarate 28mg equivalent to tenofovir alafenamide 25mg
Tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Levosert
Levonorgestrel 52mg
Intrauterine contraceptive device
Allergan New Zealand Limited
Odyssea Pharma S.A., Grace-Hollogne, Belgium
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Tenofovir Emtricitabine Mylan
Emtricitabine 200mg
Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Pithampur, India
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Dated this 10th day of February 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