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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Cystadane
Betaine 180g
Powder for oral solution
Emerge Health New Zealand Limited
Ropack Inc, Montreal, Canada
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Domperidone
Domperidone maleate 12.72mg equivalent to domperidone 10mg
Tablet
Medreich New Zealand Limited
Medreich Limited, Bangalore, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Lonquex
Lipegfilgrastim 10mg/mL
Solution for injection
Teva Pharma (New Zealand) Limited
IDT Biologika GmbH, Dessau-Rosslau, Germany
Teva Pharmaceutical Industries Limited, Kfar Saba, Israel
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Macrogol and Electrolytes
Macrogol 3350 13.125g
Potassium chloride 0.0466g
Sodium bicarbonate 0.1785g
Sodium chloride 0.3507g
Powder for oral solution
Teva Pharma (New Zealand) Limited
Klocke Pharma-Service GmbH, Appenweier, Germany
Hermes Pharma GmbH, Wolfsberg, Austria
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Macrogol and Electrolytes Paediatric
Macrogol 3350 6.5625g
Potassium chloride 0.0233g
Sodium bicarbonate 0.0893g
Sodium chloride 0.1754g
Powder for oral solution
Teva Pharma (New Zealand) Limited
Klocke Pharma-Service GmbH, Appenweier, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Medreich Domperidone
Domperidone maleate 12.72mg equivalent to domperidone 10mg
Tablet
Medreich New Zealand Limited
Medreich Limited, Bangalore, India
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Dated this 18th day of May 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