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: 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
Ritonavir 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:
|
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 5th day of August 2016.
SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).