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 Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Aesica Queenborough Limited, Kent, United Kingdom 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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Tamiflu Oseltamivir phosphate 39.4mg/g equivalent to oseltamivir 6mg/mL when reconstituted with 55mL of water Powder for oral suspension Roche Products (NZ) Limited Rottendorf Pharma GmbH, Ennigerloh, Germany
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Dated this 6th day of April 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).