β¨ Medicine Registration Notices
NEW ZEALAND GAZETTE, No. 90 β 20 AUGUST 2015
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 200mg
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
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
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π₯
Registration of Viekira Pak-RBV
(continued from previous page)
π₯ Health & Social WelfareMedicines, Registration, Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, Ribavirin, Film coated tablet, AbbVie
NZ Gazette 2015, No 90