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 Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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FluQuadri Influenza virus A/California/7/2009 (H1N1) – like strain 15mcg Influenza virus A/Victoria/361/2011 (H3N2) – like strain 15mcg Influenza virus B/Brisbane/60/2008 – like strain 15mcg Influenza virus B/Massachusetts/2/2012 – like strain 15mcg Suspension for injection sanofi-aventis new zealand limited Sanofi Pasteur Inc, Pennsylvania, United States of America
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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FluQuadri Junior Influenza virus A/California/7/2009 (H1N1) – like strain 7.5mcg Influenza virus A/Victoria/361/2011 (H3N2) – like strain 7.5mcg Influenza virus B/Brisbane/60/2008 – like strain 7.5mcg Influenza virus B/Massachusetts/2/2012 – like strain 7.5mcg Suspension for injection sanofi-aventis new zealand limited Sanofi Pasteur Inc, Pennsylvania, United States of America
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Levoclear Levocetirizine hydrochloride 5mg Film coated tablet AFT Pharmaceuticals Limited Zaklad Farmaceutyczny Adamed Pharma S.A., Ksawerow, Poland
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Product: Active Ingredient/s: 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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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Zaltrap Aflibercept 25mg/mL (100mg/4mL) Concentrate for infusion sanofi-aventis new zealand limited Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Zaltrap Aflibercept 25mg/mL (200mg/8mL) Concentrate for infusion sanofi-aventis new zealand limited Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany
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Dated this 12th day of December 2014.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).