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
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Hemlibra
Emicizumab 30mg/mL
Solution for injection
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Hemlibra (60mg/0.4mL)
Emicizumab 30mg/mL
Solution for injection
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Hemlibra (105mg/0.7mL)
Emicizumab 30mg/mL
Solution for injection
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Hemlibra (150mg/1mL)
Emicizumab 30mg/mL
Solution for injection
Roche Products (NZ) Limited
Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan
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|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Tecentriq
Atezolizumab 1200mg
Concentrate for infusion
Roche Products (NZ) Limited
Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
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Dated this 7th day of March 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz