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:
Manufacturers:

Aldurazyme
Laronidase 0.58mg/mL
Concentrate for infusion
Sanofi-Aventis New Zealand Limited
Jubilant HollisterStier LLC, Washington, United States of America
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Alecensa
Alectinib hydrochloride 161.33mg equivalent to alectinib 150mg
Capsule
Roche Products (NZ) Limited
Excella GmbH & Co KG, Feucht, Germany

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

Apo-Sitagliptin
Sitagliptin phosphate monohydrate 32.125mg equivalent to sitagliptin 25mg
Film coated tablet
Apotex NZ Limited
Apotex Inc, Toronto, Canada

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

Apo-Sitagliptin
Sitagliptin phosphate monohydrate 64.25mg equivalent to sitagliptin 50mg
Film coated tablet
Apotex NZ Limited
Apotex Inc, Toronto, Canada

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

Apo-Sitagliptin
Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg
Film coated tablet
Apotex NZ Limited
Apotex Inc, Toronto, Canada

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

Atazanavir Mylan
Atazanavir sulfate 170.85mg equivalent to atazanavir 150mg
Capsule
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, India

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

Atazanavir Mylan
Atazanavir sulfate 227.8mg equivalent to atazanavir 200mg
Capsule
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, India

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

Atazanavir Mylan
Atazanavir sulfate 341.7mg equivalent to atazanavir 300mg
Capsule
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, India

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

Calcium Folinate Sandoz 30mg/3mL
Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg/mL
Concentrate for injection
Novartis New Zealand Limited
Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

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

Calcium Folinate Sandoz 50mg/5mL
Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg/mL
Concentrate for injection
Novartis New Zealand Limited
Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

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

Calcium Folinate Sandoz 100mg/10mL
Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg/mL
Concentrate for injection
Novartis New Zealand Limited
Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

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

Calcium Folinate Sandoz 200mg/20mL
Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg/mL
Concentrate for injection
Novartis New Zealand Limited
Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

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

Calcium Folinate Sandoz 350mg/35mL
Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg/mL
Concentrate for injection
Novartis New Zealand Limited
Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

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

Calcium Folinate Sandoz 500mg/50mL
Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg/mL
Concentrate for injection
Novartis New Zealand Limited
Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

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

Calcium Folinate Sandoz 1000mg/100mL
Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg/mL
Concentrate for injection
Novartis New Zealand Limited
Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany

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

Cortiment
Budesonide 9mg
Modified release tablet
Pharmaco (NZ) Limited
Cosmo SpA, Milan, Italy

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

Ocrevus
Ocrelizumab 300mg
Concentrate for infusion
Roche Products (NZ) Limited
Roche Diagnostics GmbH, Mannheim, Germany

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

Olanzapine
Olanzapine 2.5mg
Film coated tablet
REX Medical Limited
Cipla Limited, Daund, India

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

Olanzapine
Olanzapine 5mg
Film coated tablet
REX Medical Limited
Cipla Limited, Daund, India

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

Olanzapine
Olanzapine 7.5mg
Film coated tablet
REX Medical Limited
Cipla Limited, Daund, India

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

Olanzapine
Olanzapine 10mg
Film coated tablet
REX Medical Limited
Cipla Limited, Daund, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Sensodyne True White (Mint)
Potassium nitrate 5%w/w
Sodium fluoride 0.3152%w/w
Toothpaste
GlaxoSmithKline Consumer Healthcare New Zealand Limited
Neocosmed Co Limited, Pathumthani, Thailand

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Sensodyne True White (Extra fresh)
Potassium nitrate 5%w/w
Sodium fluoride 0.3152%w/w
Toothpaste
GlaxoSmithKline Consumer Healthcare New Zealand Limited
Neocosmed Co Limited, Pathumthani, Thailand

Dated this 19th day of December 2017.

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