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 Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Esbriet Pirfenidone 267mg Film coated tablet Roche Products (NZ) Limited Roche SpA, Milan, Italy
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Esbriet Pirfenidone 534mg Film coated tablet Roche Products (NZ) Limited Roche SpA, Milan, Italy
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Esbriet Pirfenidone 801mg Film coated tablet Roche Products (NZ) Limited Roche SpA, Milan, Italy
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Keytruda Pembrolizumab 25mg/mL Concentrate for infusion Merck Sharp & Dohme (New Zealand) Limited MSD International GmbH (Ireland), Carlow, Ireland
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Phosphate Phebra Monobasic sodium phosphate 1.936g equivalent to phosphorus 500mg Effervescent tablet KSJ Pharmatech Limited Alpex Pharma SA, Mezzovico, Switzerland
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Venlafaxine Mylan Venlafaxine hydrochloride 42.42mg equivalent to venlafaxine 37.5mg Modified release capsule Mylan New Zealand Limited Mylan Laboratories Limited, Sinnar, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Venlafaxine Mylan Venlafaxine hydrochloride 84.85mg equivalent to venlafaxine 75mg Modified release capsule Mylan New Zealand Limited Mylan Laboratories Limited, Sinnar, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Venlafaxine Mylan Venlafaxine hydrochloride 169.7mg equivalent to venlafaxine 150mg Modified release capsule Mylan New Zealand Limited Mylan Laboratories Limited, Sinnar, India
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Dated this 23rd day of March 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).