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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Belkyra
Deoxycholic acid 10mg/mL
Solution for injection
Allergan New Zealand Limited
Hospira Inc, Kansas, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Darzalex
Daratumumab 100mg/5mL
Concentrate for infusion
Janssen-Cilag (New Zealand) Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Cilag AG, Schaffhausen, Switzerland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Darzalex
Daratumumab 400mg/20mL
Concentrate for infusion
Janssen-Cilag (New Zealand) Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Microshield Angel Clear Antimicrobial Hand Gel
Ethanol 66.01%w/w
Topical gel
Schulke New Zealand Limited
Ensign Laboratories Pty Limited, Melbourne, Australia
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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SteroClear
Budesonide 1mg/mL
Nasal spray suspension
AFT Pharmaceuticals Limited
Jewim Pharmaceutical (Shandong) Co Limited, Taian Shi, China
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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SteroClear
Budesonide 2mg/mL
Nasal spray suspension
AFT Pharmaceuticals Limited
Jewim Pharmaceutical (Shandong) Co Limited, Taian Shi, China
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Voriconazole 200mg
Voriconazole 200 mg
Powder for infusion
Max Health Limited
Anfarm Hellas SA, Schimatari, Greece
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Dated this 23rd day of November 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz