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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Apo-Cilazapril
Cilazapril monohydrate 1.0425mg equivalent to Cilazapril 1mg
Film coated tablet
Apotex New Zealand Limited
Apotex Inc, Weston, Canada
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Azelastine-PROTECT
Azelastine hydrochloride 0.5mg/mL
Eye drops, solution
AFT Pharmaceuticals Limited
Ursapharm Arzneimittel GmbH, Saarbrucken, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
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Droperidol Panpharma
Droperidol 0.5mg/mL
Solution for injection
Multichem New Zealand Limited
Rotexmedica GmbH Arzneimittelwerk, Trittau, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Droperidol Panpharma
Droperidol 2.5mg/mL
Solution for injection
Multichem New Zealand Limited
Rotexmedica GmbH Arzneimittelwerk, Trittau, Germany
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Promozio 250/100
Atovaquone 250mg
Proguanil hydrochloride 100mg
Coated tablet
Sanofi-Aventis New Zealand Limited
Glenmark Pharmaceuticals Limited, Bardez, India
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Product:
Active Ingredient:
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New Zealand Sponsor:
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Zoledronic acid Mylan
Zoledronic acid monohydrate 5.33mg
equivalent to zolendronic acid (anhydrous) 5mg
Solution for infusion
Mylan New Zealand Limited
Mylan Laboratories Limited, Anekal, India
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Dated this 17th day of July 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