Gazette.govt.nzPursuant 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: | MMR II Vaccine |
| Active Ingredients: | Measles vaccine 1000TCID50 Mumps vaccine 12500TCID50 Rubella vaccine 1000TCID50 |
| Dosage Form: | Suspension for injection with diluent |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturers: | Merck Sharp & Dohme Corp, Pennsylvania, United States of America Merck Sharp & Dohme Corp, Vaccine Manufacturing Facility, North Carolina, United States of America |
| Product: | Xigduo XR |
| Active Ingredients: | Dapagliflozin propanediol monohydrate 6.15mg equivalent to dapagliflozin 5mg Metformin hydrochloride 1000mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturers: | Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
| Product: | Xigduo XR |
| Active Ingredients: | Dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10mg Metformin hydrochloride 500mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturers: | Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
| Product: | Xigduo XR |
| Active Ingredients: | Dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10mg Metformin hydrochloride 1000mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturers: | Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
Dated this 3rd day of October 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).