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Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Publication Date
14 Mar 2019

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2019-go1100
Title
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File Type and Size
PDF (29 KB)

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:

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 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 (105mg/0.7mL)
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 (150mg/1mL)
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:
Manufacturers:

Tecentriq
Atezolizumab 1200mg
Concentrate for infusion
Roche Products (NZ) Limited
Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland

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).