Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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:

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

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

Ritonavir 200mg
Film coated tablet
DSM Pharmaceuticals Inc, North Carolina, United States of America
AbbVie Limited

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

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

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

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).