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 Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Betaxolol
Betaxolol hydrochloride 0.56%w/v equivalent to betaxolol 0.5%
Eye drops, solution
REX Medical Limited
Cipla Limited, Verna, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Entecavir Mylan
Entecavir monohydrate 0.53mg equivalent to entecavir (anhydrous) 0.5mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Entecavir Mylan
Entecavir monohydrate 1.06mg equivalent to entecavir (anhydrous) 1mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Latanoprost
Latanoprost 0.05mg/mL
Eye drops, solution
Teva Pharma (New Zealand) Limited
FDC Limited, Aurangabad, India
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Maviret
Glecaprevir 100mg
Pibrentasvir 40mg
Film coated tablet
AbbVie Limited
AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany
Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Metaraminol
Metaraminol tartrate 19mg/mL equivalent to metaraminol base 10mg/mL
Solution for injection
Max Health Limited
Torbay and South Devon NHS Foundation Trust, Paignton, United Kingdom
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Dated this 18th day of June 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