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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Prevenar 13 Pneumococcal polysaccharide serotype 6A 2.2mcg Pneumococcal polysaccharide type 1 2.2mcg Pneumococcal polysaccharide type 14 2.2mcg Pneumococcal polysaccharide type 18C 2.2mcg Pneumococcal polysaccharide type 19A 2.2mcg Pneumococcal polysaccharide type 19F 2.2mcg Pneumococcal polysaccharide type 23F 2.2mcg Pneumococcal polysaccharide type 3 2.2mcg Pneumococcal polysaccharide type 4 2.2mcg Pneumococcal polysaccharide type 5 2.2mcg Pneumococcal polysaccharide type 6B 4.4mcg Pneumococcal polysaccharide type 7F 2.2mcg Pneumococcal polysaccharide type 9V 2.2mcg Suspension for injection Pfizer New Zealand Limited Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, New York, United States of America Baxter BioPharma Solutions LLC, Indiana, United States of America Pfizer Ireland Pharmaceuticals, Dublin, Ireland
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Product: Component 1: Active Ingredients:
Dosage Form: Manufacturer: Component 2: Active Ingredient: Dosage Form: Manufacturer: New Zealand Sponsor:
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Viekira Pak
Ombitasvir 12.5mg Paritaprevir 75mg Ritonavir 50mg Film coated tablet Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg Film coated tablet AbbVie Ireland NL B.V., Sligo, Ireland AbbVie Limited
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Product: Component 1: Active Ingredients:
Dosage Form: Manufacturer: Component 2: Active Ingredient: Dosage Form: Manufacturer: Component 3: Active Ingredient: Dosage Form: Manufacturer: New Zealand Sponsor:
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Viekira Pak-RBV
Ombitasvir 12.5mg Paritaprevir 75mg Ritonavir 50mg Film coated tablet Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg Film coated tablet AbbVie Ireland NL B.V., Sligo, Ireland
Ribavirin 200mg Film coated tablet DSM Pharmaceuticals Inc, North Carolina, United States of America AbbVie Limited
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Product: Component 1: Active Ingredients:
Dosage Form: Manufacturer: Component 2: Active Ingredient: Dosage Form: Manufacturer: Component 3: Active Ingredient: Dosage Form: Manufacturer: New Zealand Sponsor:
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Viekira Pak-RBV
Ombitasvir 12.5mg Paritaprevir 75mg Ritonavir 50mg Film coated tablet Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg Film coated tablet AbbVie Ireland NL B.V., Sligo, Ireland
Ribavirin 400mg Film coated tablet DSM Pharmaceuticals Inc, North Carolina, United States of America AbbVie Limited
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Product: Component 1: Active Ingredients:
Dosage Form: Manufacturer: Component 2: Active Ingredient: Dosage Form: Manufacturer: Component 3: Active Ingredient: Dosage Form: Manufacturer: New Zealand Sponsor:
|
Viekira Pak-RBV
Ombitasvir 12.5mg Paritaprevir 75mg Ritonavir 50mg Film coated tablet Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg Film coated tablet AbbVie Ireland NL B.V., Sligo, Ireland
Ribavirin 600mg Film coated tablet DSM Pharmaceuticals Inc, North Carolina, United States of America AbbVie Limited
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Product: Component 1: Active Ingredients:
Dosage Form: Manufacturer: Component 2: Active Ingredient: Dosage Form: Manufacturer: Component 3: Active Ingredient: Dosage Form: Manufacturer: Component 4: Active Ingredient: Dosage Form: Manufacturer: New Zealand Sponsor:
|
Viekira Pak-RBV
Ombitasvir 12.5mg Paritaprevir 75mg Ritonavir 50mg Film coated tablet Fournier Laboratories Ireland Limited, County Cork, Ireland
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg Film coated tablet AbbVie Ireland NL B.V., Sligo, Ireland
Ribavirin 400mg Film coated tablet DSM Pharmaceuticals Inc, North Carolina, United States of America
Ribavirin 600mg Film coated tablet DSM Pharmaceuticals Inc, North Carolina, United States of America AbbVie Limited
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Dated this 21st day of August 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).