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 set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Abilify Maintena
Aripiprazole monohydrate 312.05mg equivalent to Aripiprazole 300mg
Injection with diluent
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Otsuka Pharmaceutical Co Limited, Tokushima, Japan

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Abilify Maintena
Aripiprazole monohydrate 416.07mg equivalent to Aripiprazole 400mg
Injection with diluent
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Otsuka Pharmaceutical Co Limited, Tokushima, Japan

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Apo-Bimatoprost
Bimatoprost 0.3mg/mL
Eye drops, solution
Apotex NZ Limited
Apotex Inc, Ontario, Canada
Sterigenics EO Canada Inc., Ontario, Canada

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Benadryl Chesty Forte
Bromhexine hydrochloride 0.8mg/mL
Guaifenesin 20mg/mL
Oral solution
Johnson & Johnson (New Zealand) Limited
Shanghai Johnson & Johnson Pharmaceuticals Limited, Shanghai, China

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Plegridy
Peginterferon beta-1a 125mcg
Solution for injection
Biogen Idec NZ Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Component 1:
Active Ingredient:
Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Plegridy

Peginterferon beta-1a 94mcg
Solution for injection

Peginterferon beta-1a 63mcg
Solution for injection
Biogen Idec NZ Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Tranexamic Acid Link
Tranexamic acid 100mg/mL
Solution for injection
Link Pharmaceuticals Limited
Novell Pharmaceutical Laboratories PT., Bogor, Indonesia

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

Ribavirin 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

Product:
Active Ingredient
Dosage Form:
New Zealand Sponsor:
Manufacturers:

VIMIZIM
Elosulfase alfa 1mg/mL
Concentrate for infusion
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Dated this 14th day of August 2015.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).