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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Gees Linctus Opium tincture 1.369%w/w Squill oxymel 3.78%w/w Linctus 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 Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Nicabate Clear Nicotine 114mg equivalent to 21mg delivered in 24 hours Transdermal patch GlaxoSmithKline (NZ) Limited GlaxoSmithKline Dungarvan Limited, County Waterford, Ireland
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Nicabate Clear Nicotine 78mg equivalent to 14mg delivered in 24 hours Transdermal patch GlaxoSmithKline (NZ) Limited GlaxoSmithKline Dungarvan Limited, County Waterford, Ireland
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Nicabate Clear Nicotine 36mg equivalent to 7mg delivered in 24 hours Transdermal patch GlaxoSmithKline (NZ) Limited GlaxoSmithKline Dungarvan Limited, County Waterford, Ireland
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Paracetamol Children 6–12 years Paracetamol 5%w/v Oral suspension Multichem NZ Limited Meditab Specialities Pvt Limited, Maharashtra, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Risperidone Mylan Risperidone 0.5mg Film coated tablet Mylan New Zealand Limited Mylan Laboratories Limited, Maharashtra State, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Risperidone Mylan Risperidone 1mg Film coated tablet Mylan New Zealand Limited Mylan Laboratories Limited, Maharashtra State, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Risperidone Mylan Risperidone 2mg Film coated tablet Mylan New Zealand Limited Mylan Laboratories Limited, Maharashtra State, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Risperidone Mylan Risperidone 3mg Film coated tablet Mylan New Zealand Limited Mylan Laboratories Limited, Maharashtra State, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Risperidone Mylan Risperidone 4mg Film coated tablet Mylan New Zealand Limited Mylan Laboratories Limited, Maharashtra State, India
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Dated this 5th day of February 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).