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: |
Kombiglyze XR |
Active Ingredients: |
Metformin hydrochloride 500mg Saxagliptin 5mg |
Dosage Form: |
Modified release tablet |
New Zealand Sponsor: |
AstraZeneca Limited |
Manufacturer: |
AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
|
|
Product: |
Kombiglyze XR |
Active Ingredients: |
Metformin hydrochloride 1000mg Saxagliptin 2.5mg |
Dosage Form: |
Modified release tablet |
New Zealand Sponsor: |
AstraZeneca Limited |
Manufacturer: |
AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
|
|
Product: |
Kombiglyze XR |
Active Ingredients: |
Metformin hydrochloride 1000mg Saxagliptin 5mg |
Dosage Form: |
Modified release tablet |
New Zealand Sponsor: |
AstraZeneca Limited |
Manufacturer: |
AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
Dated this 8th day of November 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).