β¨ Medicine Approval Notices
NEW ZEALAND GAZETTE, No. 86 β 24 AUGUST 2017
Product:
Viekira Pak-RBV
Component 1:
Active Ingredients:
Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Dosage Form:
Film coated tablet
Manufacturer:
Fournier Laboratories Ireland Limited, County Cork, Ireland
Component 2:
Active Ingredient:
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Dosage Form:
Film coated tablet
Manufacturer:
AbbVie Ireland NL B.V., Sligo, Ireland
Component 3:
Active Ingredient:
Ribavirin 400mg
Dosage Form:
Film coated tablet
Manufacturer:
DSM Pharmaceuticals Inc, North Carolina, United States of America
New Zealand Sponsor:
AbbVie Limited
Product:
Viekira Pak-RBV
Component 1:
Active Ingredients:
Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Dosage Form:
Film coated tablet
Manufacturer:
Fournier Laboratories Ireland Limited, County Cork, Ireland
Component 2:
Active Ingredient:
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Dosage Form:
Film coated tablet
Manufacturer:
AbbVie Ireland NL B.V., Sligo, Ireland
Component 3:
Active Ingredient:
Ribavirin 600mg
Dosage Form:
Film coated tablet
Manufacturer:
DSM Pharmaceuticals Inc, North Carolina, United States of America
New Zealand Sponsor:
AbbVie Limited
Product:
Viekira Pak-RBV
Component 1:
Active Ingredients:
Ombitasvir 12.5mg
Paritaprevir 75mg
Ritonavir 50mg
Dosage Form:
Film coated tablet
Manufacturer:
Fournier Laboratories Ireland Limited, County Cork, Ireland
Component 2:
Active Ingredient:
Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250mg
Dosage Form:
Film coated tablet
Manufacturer:
AbbVie Ireland NL B.V., Sligo, Ireland
Component 3:
Active Ingredient:
Ribavirin 400mg
Dosage Form:
Film coated tablet
Manufacturer:
DSM Pharmaceuticals Inc, North Carolina, United States of America
Component 4:
Active Ingredient:
Ribavirin 600mg
Dosage Form:
Film coated tablet
Manufacturer:
DSM Pharmaceuticals Inc, North Carolina, United States of America
New Zealand Sponsor:
AbbVie Limited
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).
Provisional Consent to the Distribution of a New Medicine
Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
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β¨ LLM interpretation of page content
π₯
Approval of Viekira Pak-RBV for Distribution
(continued from previous page)
π₯ Health & Social Welfare21 August 2017
Medicine, Treatment, Hepatitis C, Ribavirin, Approval
- Chris James, Group Manager, Medsafe, Ministry of Health
π₯ Provisional Consent to the Distribution of a New Medicine
π₯ Health & Social WelfareMedicine, Provisional Consent, Distribution, Medicines Act 1981
NZ Gazette 2017, No 86