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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:

Arnuity Ellipta
Fluticasone furoate 100mcg
Powder for inhalation
GlaxoSmithKline (NZ) Limited
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire,
United Kingdom

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

Arnuity Ellipta
Fluticasone furoate 200mcg
Powder for inhalation
GlaxoSmithKline (NZ) Limited
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire,
United Kingdom

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

Darunavir Mylan
Darunavir 300mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India

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

Darunavir Mylan
Darunavir 400mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India

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

Darunavir Mylan
Darunavir 600mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India

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

Dipyridamole SR Actavis
Dipyridamole 150mg
Modified release capsule
Actavis New Zealand Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

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

Dipyridamole SR Actavis
Dipyridamole 200mg
Modified release capsule
Actavis New Zealand Limited
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturers:

Epclusa
Sofosbuvir 400mg
Velpatasvir 100mg
Tablet
Gilead Sciences (NZ)
Gilead Sciences Ireland UC, County Cork, Ireland
Patheon Inc, Mississauga, Canada

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

Eptifibatide Mylan
Eptifibatide 0.75mg/mL
Solution for infusion
Mylan New Zealand Limited
Mylan Laboratories Limited, Bangalore, India

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

Eptifibatide Mylan
Eptifibatide 2mg/mL
Solution for injection
Mylan New Zealand Limited
Mylan Laboratories Limited, Bangalore, India

Product:
Active Ingredients:



Dosage Form:

New Zealand Sponsor:
Manufacturer:

Genvoya
Cobicistat 150mg
Elvitegravir 150mg
Emtricitabine 200mg
Tenofovir alafenamide 10mg
Tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada

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

Leuprorelin Sandoz
Leuprorelin acetate 3.78mg equivalent to leuprorelin 3.6mg
Subcutaneous implant
Novartis New Zealand Limited
EVER Pharma Jena GmbH, Jena, Germany

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

Leuprorelin Sandoz
Leuprorelin acetate 5.25mg equivalent to leuprorelin 5mg
Subcutaneous implant
Novartis New Zealand Limited
EVER Pharma Jena GmbH, Jena, Germany

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

Lynparza
Olaparib 50mg
Capsule
AstraZeneca Limited
Patheon Pharmaceuticals Inc, Ohio, United States of America

Dated this 4th day of November 2016.

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