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Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Publication Date
9 Jul 2015

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2015-go3978

Issue Number

74
Title
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File Type and Size
PDF (22 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 set out in the Schedule hereto:

Schedule

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

Advate
Octocog alfa 4000IU
Injection with diluent
Baxalta New Zealand Limited
Baxter Bioscience Manufacturing SARL, Neuchatel, Switzerland
Baxter AG, Vienna, Austria

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Kombiglyze
Metformin hydrochloride 500mg
Saxagliptin 2.5mg
Film coated tablet
AstraZeneca Limited
Bristol-Myers Squibb Company, Indiana, United States of America

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Kombiglyze
Metformin hydrochloride 850mg
Saxagliptin 2.5mg
Film coated tablet
AstraZeneca Limited
Bristol-Myers Squibb Company, Indiana, United States of America

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Kombiglyze
Metformin hydrochloride 1000mg
Saxagliptin 2.5mg
Film coated tablet
AstraZeneca Limited
Bristol-Myers Squibb Company, Indiana, United States of America

Dated this 2nd day of July 2015.

Dr DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).