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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Gliolan
Aminolevulinic acid hydrochloride 1.5g
Powder for oral solution
Specialised Therapeutics Limited
IDT Biologika GmbH, Dessau Rosslau, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Inflectra
Infliximab 100mg
Powder for injection
Pharmbio Pty Limited
Mustafa Nevzat llac Sanayii A.S., Istanbul, Turkey
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Kevtam
Levetiracetam 250mg
Film coated tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Kevtam
Levetiracetam 500mg
Film coated tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Kevtam
Levetiracetam 750mg
Film coated tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Kevtam
Levetiracetam 1000mg
Film coated tablet
Mylan New Zealand Limited
Mylan Pharmaceuticals Inc, West Virginia, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Remsima
Infliximab 100mg
Powder for injection
Pharmbio Pty Limited
Mustafa Nevzat llac Sanayii A.S., Istanbul, Turkey
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Tramadol Actavis
Tramadol hydrochloride 50mg/mL
Solution for injection
Actavis New Zealand Limited
Laboratorios Norman SA, Madrid, Spain
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Dated this 11th day of September 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
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