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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Humira Adalimumab 10mg/0.2mL Solution for injection AbbVie Limited Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Humira Adalimumab 20mg/0.4mL Solution for injection AbbVie Limited Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Humira Adalimumab 50mg/mL Solution for injection AbbVie Limited Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Humira Pen Adalimumab 50mg/mL Solution for injection AbbVie Limited Aesica Queenborough Limited, Kent, United Kingdom Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Xeomin Botulinum toxin type A 50LD50 Units Powder for injection New Zealand Medical & Scientific Limited Merz Pharma GmbH & Co KGaA, Dessau-Rosslau, Germany IDT Biologika GmbH, Dessau-Rosslau, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Xeomin Botulinum toxin type A 100LD50 Units Powder for injection New Zealand Medical & Scientific Limited Merz Pharma GmbH & Co KGaA, Dessau-Rosslau, Germany IDT Biologika GmbH, Dessau-Rosslau, Germany
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Dated this 26th day of January 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).