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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Jakavi
Ruxolitinib phosphate 6.6mg equivalent to ruxolitinib 5mg
Tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Jakavi
Ruxolitinib phosphate 19.8mg equivalent to ruxolitinib 15mg
Tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Jakavi
Ruxolitinib phosphate 26.4mg equivalent to ruxolitinib 20mg
Tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Onglyza
Saxagliptin hydrochloride 2.98mg equivalent to saxagliptin 2.5mg
Film coated tablet
AstraZeneca Limited
AstraZeneca Pharmaceuticals LP, Indiana, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Onglyza
Saxagliptin hydrochloride 5.95mg equivalent to saxagliptin 5mg
Film coated tablet
AstraZeneca Limited
AstraZeneca Pharmaceuticals LP, Indiana, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Xarelto
Rivaroxaban 10mg
Film coated tablet
Bayer New Zealand Limited
Bayer AG, Leverkusen, Germany
Bayer Healthcare Manufacturing Srl, Milano, Italy
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Xarelto
Rivaroxaban 15mg
Film coated tablet
Bayer New Zealand Limited
Bayer AG, Leverkusen, Germany
Bayer Healthcare Manufacturing Srl, Milano, Italy
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Xarelto
Rivaroxaban 20mg
Film coated tablet
Bayer New Zealand Limited
Bayer AG, Leverkusen, Germany
Bayer Healthcare Manufacturing Srl, Milano, Italy
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Dated this 1st day of April 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz