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 Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Boostrix Diphtheria toxoid, adsorbed 2IU Pertactin 2.5mcg Pertussis filamentous haemagglutinin 8mcg Pertussis toxoid, adsorbed 8mcg Tetanus toxoid, adsorbed 20IU Suspension for injection GlaxoSmithKline (NZ) Limited GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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DBL™ Mitoxantrone Hydrochloride Injection Concentrate Mitoxantrone hydrochloride 2.33mg/mL equivalent to Mitoxantrone 2mg/mL Concentrate for infusion Hospira NZ Limited Hospira Australia Pty Limited, Melbourne, Australia Zydus Hospira Oncology Limited (ZHOPL), Ahmedabad, India
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Simponi Golimumab 50mg Solution for injection Janssen-Cilag (New Zealand) Limited Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Simponi SmartJect Injector Golimumab 50mg Solution for injection Janssen-Cilag (New Zealand) Limited Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
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Dated this 20th day of November 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).