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:
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New Zealand Sponsor:
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5% Glucose (Viaflo)
Glucose monohydrate 5%w/v
Solution for infusion
Baxter Healthcare Limited
Baxter Healthcare Pty Limited, Sydney, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
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Adynovate
Rurioctocog alfa pegol 250IU
Powder for injection
Shire New Zealand Limited
Baxalta Manufacturing SARL, Neuchatel, Switzerland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Adynovate
Rurioctocog alfa pegol 500IU
Powder for injection
Shire New Zealand Limited
Baxalta Manufacturing SARL, Neuchatel, Switzerland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Adynovate
Rurioctocog alfa pegol 1000IU
Powder for injection
Shire New Zealand Limited
Baxalta Manufacturing SARL, Neuchatel, Switzerland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Adynovate
Rurioctocog alfa pegol 2000IU
Powder for injection
Shire New Zealand Limited
Baxalta Manufacturing SARL, Neuchatel, Switzerland
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Brufen Extra
Ibuprofen 200mg
Paracetamol 500mg
Film coated tablet
Mylan New Zealand Limited
Medreich Limited, Bangalore, India
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Dimetapp Multi Symptom Cold & Flu (Pharmacy only)
Paracetamol 300mg
Phenylephrine hydrochloride 5mg
Liquid filled capsule
Pfizer New Zealand Limited
Catalent Australia Pty Limited, Melbourne, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
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Kyprolis
Carfilzomib 30mg
Powder for infusion
Amgen New Zealand Limited
Patheon Manufacturing Services LLC, North Carolina, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
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Kyprolis
Carfilzomib 60mg
Powder for infusion
Amgen New Zealand Limited
Patheon Manufacturing Services LLC, North Carolina, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Teicoplanin Mylan
Teicoplanin 400mg
Powder for injection
Mylan New Zealand Limited
Mylan Laboratories Limited, Bangalore, India
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Dated this 14th day of December 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