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:
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New Zealand Sponsor:
Manufacturer:
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Fardoben Gargle
Benzydamine hydrochloride 0.15%w/v
Chlorhexidine gluconate 0.12%w/v
Mouthwash
Deva Holdings NZ Limited
Deva Holding AS, Tekirdag, Turkey
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Product:
Active Ingredients:
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New Zealand Sponsor:
Manufacturer:
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Fardoben Throat Spray
Benzydamine hydrochloride 0.15%w/v
Chlorhexidine gluconate 0.12%w/v
Oral spray
Deva Holdings NZ Limited
Deva Holding AS, Tekirdag, Turkey
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Nicorette Fruitdrops
Nicotine polacrilex 10mg equivalent to nicotine 2mg
Lozenge
Johnson & Johnson (New Zealand) Limited
McNeil AB, Helsingborg, Sweden
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Product:
Active Ingredient:
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New Zealand Sponsor:
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Nicorette Fruitdrops
Nicotine polacrilex 20mg equivalent to nicotine 4mg
Lozenge
Johnson & Johnson (New Zealand) Limited
McNeil AB, Helsingborg, Sweden
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Product:
Active Ingredient:
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New Zealand Sponsor:
Manufacturer:
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Pemetrexed Juno
Pemetrexed disodium hemipentahydrate 120.81mg equivalent to pemetrexed 100mg
Powder for infusion
Juno Pharmaceuticals NZ Limited
Gland Pharma Limited, Visakhapatnam, India
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Product:
Active Ingredient:
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New Zealand Sponsor:
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Pemetrexed Juno
Pemetrexed disodium hemipentahydrate 604.05mg equivalent to pemetrexed 500mg
Powder for infusion
Juno Pharmaceuticals NZ Limited
Gland Pharma Limited, Visakhapatnam, India
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Dated this 11th day of August 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