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
Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Codral Cold & Flu Paracetamol 500mg Phenylephrine hydrochloride 5mg Film coated tablet Johnson & Johnson (New Zealand) Limited Janssen-Cilag, Val de Reuil, France
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Product: Component 1: Active Ingredients:
Dosage Form: Component 2: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Codral Day & Night Cold & Flu
Paracetamol 500mg Phenylephrine hydrochloride 5mg Film coated tablet
Chlorphenamine maleate 2mg Paracetamol 500mg Phenylephrine hydrochloride 5mg Film coated tablet Johnson & Johnson (New Zealand) Limited Janssen-Cilag, Val de Reuil, France
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Decongestant 12 Hour Nasal Spray Oxymetazoline hydrochloride 0.5mg/mL Nasal spray solution PSM Healthcare Limited trading as API Consumer Brands PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Dimetapp Cold & Flu Paracetamol 300mg Phenylephrine hydrochloride 5mg Liquid filled capsule Pfizer New Zealand Limited Catalent Australia Pty Limited, Melbourne, Australia
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer/s:
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Dimetapp Multi Symptom Cold & Flu 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: Manufacturer:
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Esmya Ulipristal acetate 5mg Tablet Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics Cenexi SAS, Paris, France
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Paracetamol OptiTab (General sale) Paracetamol 500mg Film coated tablet Generic Partners (NZ) Limited Gracure Pharmaceuticals Limited, Bhiwadi, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Paracetamol OptiTab (Pharmacy only) Paracetamol 500mg Film coated tablet Generic Partners (NZ) Limited Gracure Pharmaceuticals Limited, Bhiwadi, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Stomach Soothe Hyoscine butylbromide 10mg Film coated tablet Teva Pharma (New Zealand) Limited PT Actavis Indonesia, Jakarta, Indonesia
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Strepfen Intensive Flurbiprofen 16.2mg/mL equivalent to 8.748mg per dose Oral spray Reckitt Benckiser (New Zealand) Limited Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Bangplee, Thailand
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Dated this 5th day of December 2017.
ALISON COSSAR, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).