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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Albey Bee Venom Bee venom 550mcg Powder for injection with diluent Ebos Group Limited Jubilant Hollister-Stier LLC, Washington, United States of America
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Albey Paper Wasp Venom Wasp venom protein 550mcg Powder for injection with diluent Ebos Group Limited Jubilant Hollister-Stier LLC, Washington, United States of America
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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Albey Yellow Jacket Venom Wasp venom protein 550mcg Powder for injection with diluent Ebos Group Limited Jubilant Hollister-Stier LLC, Washington, United States of America
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Fluarix Tetra Influenza virus A/California/7/2009 (H1N1) like strain 15mcg Influenza virus A/Texas/50/2012 (H3N2) like strain 15mcg Influenza virus B/Massachusetts/2/2012 like strain 15mcg Influenza virus B/Yamagata 16/88 15mcg Suspension for injection GlaxoSmithKline (NZ) Limited GlaxoSmithKline Biologicals (Dresden), Dresden, Germany
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Product: Component 1: Active Ingredients:
Dosage Form: Component 2: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Infanrix-Hib vaccine
Detoxified pertussis toxin 25mcg Diphtheria toxoid, adsorbed 30IU Pertactin 8mcg Pertussis filamentous haemagglutinin 25mcg Tetanus toxoid 40IU Suspension for injection
Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg Powder for injection GlaxoSmithKline (NZ) Limited GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Manufacturing SpA, Parma, Italy GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France
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Product: Component 1: Active Ingredients:
Dosage Form: Component 2: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturers:
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Infanrix-IPV+Hib
Detoxified pertussis toxin 25mcg Diphtheria toxoid, adsorbed 30IU Pertactin 8mcg Pertussis filamentous haemagglutinin 25mcg Polio virus type 1 40DAgU Polio virus type 2 8DAgU Polio virus type 3 32DAgU Tetanus toxoid, adsorbed 40IU Suspension for injection
Haemophilus influenzae vaccine, tetanus toxoid conjugate 10mcg Powder for injection GlaxoSmithKline (NZ) Limited GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium GlaxoSmithKline Manufacturing SpA, Parma, Italy GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France
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Product: Active Ingredients:
Dosage Form: New Zealand Sponsor: Manufacturers:
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Synflorix Pneumococcal Polysaccharide type 1 1mcg Pneumococcal Polysaccharide type 14 1mcg Pneumococcal Polysaccharide type 18C 3mcg Pneumococcal Polysaccharide type 19F 3mcg Pneumococcal Polysaccharide type 23F 1mcg Pneumococcal Polysaccharide type 4 3mcg Pneumococcal Polysaccharide type 5 1mcg Pneumococcal Polysaccharide type 6B 1mcg Pneumococcal Polysaccharide type 7F 1mcg Pneumococcal Polysaccharide type 9V 1mcg 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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Dated this 15th day of April 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).