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:

Aramine
Metaraminol tartrate 18.96mg/mL equivalent to metaraminol 10mg
Solution for injection
KSJ Pharmatech Limited
Phebra Pty Limited, Sydney, Australia

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Glyxambi
Empagliflozin 10mg
Linagliptin 5mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Glyxambi
Empagliflozin 25mg
Linagliptin 5mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

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

Hemlibra
Emicizumab 30mg/mL
Solution for injection
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan

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

Hemlibra (60mg/0.4mL)
Emicizumab 150mg/mL
Solution for injection
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan

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

Hemlibra (105mg/0.7mL)
Emicizumab 150mg/mL
Solution for injection
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan

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

Hemlibra (150mg/1mL)
Emicizumab 150mg/mL
Solution for injection
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan

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

Metaraminol Phebra (3mg/6mL)
Metaraminol tartrate 0.95mg/mL equivalent to metaraminol 0.5mg/mL
Solution for injection
KSJ Pharmatech Limited
Phebra Pty Limited, Sydney, Australia

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

Metaraminol Phebra (5mg/10mL)
Metaraminol tartrate 0.95mg/mL equivalent to metaraminol 0.5mg/mL
Solution for injection
KSJ Pharmatech Limited
Phebra Pty Limited, Sydney, Australia

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

Metaraminol Phebra
Metaraminol tartrate 18.96mg/mL equivalent to metaraminol 10mg
Solution for injection
KSJ Pharmatech Limited
Phebra Pty Limited, Sydney, Australia

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

Metaraminol Sandoz (3mg/6mL)
Metaraminol tartrate 0.95mg/mL equivalent to metaraminol 0.5mg/mL
Solution for injection
KSJ Pharmatech Limited
Phebra Pty Limited, Sydney, Australia

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

Metaraminol Sandoz (5mg/10mL)
Metaraminol tartrate 0.95mg/mL equivalent to metaraminol 0.5mg/mL
Solution for injection
KSJ Pharmatech Limited
Phebra Pty Limited, Sydney, Australia

Dated this 13th day of August 2018.

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