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: Manufacturers:
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Galvumet Metformin hydrochloride 850mg Vildagliptin 50mg Film coated tablet Novartis New Zealand Limited Novartis Pharma Stein AG, Stein, Switzerland Novartis Pharma Produktions GmbH, Wehr, Germany Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Tuas, Singapore
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Galvumet Metformin hydrochloride 1000mg Vildagliptin 50mg Film coated tablet Novartis New Zealand Limited Novartis Pharma Stein AG, Stein, Switzerland Novartis Pharma Produktions GmbH, Wehr, Germany Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Tuas, Singapore
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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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Nifuran Nitrofurantoin 50mg Tablet W M Bamford & Co Limited PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Nifuran Nitrofurantoin 100mg Tablet W M Bamford & Co Limited PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Riodine Antiseptic Ointment Povidone-iodine 10%w/w Topical ointment Orion Laboratories (NZ) Limited Orion Laboratories Pty Limited, Perth, Australia
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Scandonest 2% Special Adrenaline 1:100,000 Mepivacaine hydrochloride 2% Solution for injection Ivoclar Vivadent Limited Specialities Septodont, Paris, France
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Dated this 24th day of September 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).