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

Bepanthen
Dexpanthenol 50mg/g
Topical ointment
Bayer New Zealand Limited
GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Biostate
Dried factor VIII fraction 250IU
von Willebrand's factor : Ristocetin cofactor 500IU
Powder for injection
CSL Behring (NZ) Limited
CSL Behring (Australia) Pty Limited, Melbourne, Australia

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Biostate
Dried factor VIII fraction 500IU (50IU/mL)
von Willebrand's factor : Ristocetin cofactor 1000IU
Powder for injection
CSL Behring (NZ) Limited
CSL Behring (Australia) Pty Limited, Melbourne, Australia

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Biostate
Dried factor VIII fraction 500IU (1000IU/mL)
von Willebrand's factor : Ristocetin cofactor 1000IU
Powder for injection
CSL Behring (NZ) Limited
CSL Behring (Australia) Pty Limited, Melbourne, Australia

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Biostate
Dried factor VIII fraction 1000IU
von Willebrand's factor : Ristocetin cofactor 2000IU
Powder for injection
CSL Behring (NZ) Limited
CSL Behring (Australia) Pty Limited, Melbourne, Australia

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

Firazyr
Icatibant 10mg/mL
Solution for injection
Shire New Zealand Limited
Rentschler Biopharma SE, Laupheim, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Levetiracetam Actavis
Levetiracetam 250mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Teva Operations Poland Sp, Krakow, Poland

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

Levetiracetam Actavis
Levetiracetam 500mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Teva Operations Poland Sp, Krakow, Poland

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

Levetiracetam Actavis
Levetiracetam 750mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Teva Operations Poland Sp, Krakow, Poland

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

Levetiracetam Actavis
Levetiracetam 1000mg
Film coated tablet
Teva Pharma (New Zealand) Limited
Teva Operations Poland Sp, Krakow, Poland

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

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

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

Patanol Eye Drops
Olopatadine hydrochloride 0.111%w/v equivalent to olopatadine 0.1%w/v
Eye drops, solution
Novartis New Zealand Limited
Alcon Couvreur NV, Puurs, Belgium
Alcon Laboratories Inc, Texas, United States of America
Alcon Cusi SA, Barcelona, Spain
Alcon Singapore Manufacturing Pte Limited, Singapore, Singapore

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

Tagrisso
Osimertinib mesilate 47.7mg equivalent to osimertinib 40mg
Film coated tablet
AstraZeneca Limited
AstraZeneca AB, Sodertalje, Sweden

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

Tagrisso
Osimertinib mesilate 95.4mg equivalent to osimertinib 80mg
Film coated tablet
AstraZeneca Limited
AstraZeneca AB, Sodertalje, Sweden

Dated this 26th day of November 2018.

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