✨ 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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2017, No 86





✨ LLM interpretation of page content

πŸ₯ Approval of Viekira Pak-RBV for Distribution (continued from previous page)

πŸ₯ Health & Social Welfare
21 August 2017
Medicine, Treatment, Hepatitis C, Ribavirin, Approval
  • Chris James, Group Manager, Medsafe, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
Medicine, Provisional Consent, Distribution, Medicines Act 1981