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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Apo-Fingolimod Fingolimod hydrochloride 0.56mg equivalent to fingolimod 0.50mg Capsule Apotex NZ Limited Apotex Research Private Limited, Bangalore, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Ceftazidime Kabi Ceftazidime pentahydrate 1.1648g equivalent to ceftazidime 1g Powder for injection Fresenius Kabi New Zealand Limited Fresenius Kabi iPSUM S.r.l, Rovigo, Italy Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Ceftazidime Kabi Ceftazidime pentahydrate 2.3296g equivalent to ceftazidime 2g Powder for injection Fresenius Kabi New Zealand Limited Fresenius Kabi iPSUM S.r.l, Rovigo, Italy Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Repatha Evolocumab 140mg/mL Solution for injection Amgen New Zealand Limited Amgen Manufacturing Limited, Juncos, Puerto Rico
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Repatha (SureClick) Evolocumab 140mg/mL Solution for injection Amgen New Zealand Limited Amgen Manufacturing Limited, Juncos, Puerto Rico
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Tacrolimus Sandoz Tacrolimus monohydrate 0.767mg equivalent to tacrolimus 0.75mg Capsule Novartis New Zealand Limited Sandoz Private Limited, Navi Mumbai, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Tacrolimus Sandoz Tacrolimus monohydrate 2.044mg equivalent to tacrolimus 2mg Capsule Novartis New Zealand Limited Sandoz Private Limited, Navi Mumbai, India
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Dated this 7th day of June 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).