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: | Darunavir Mylan |
| Active Ingredient: | Darunavir 300mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Nashik, India |
| Product: | Darunavir Mylan |
| Active Ingredient: | Darunavir 400mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Nashik, India |
| Product: | Darunavir Mylan |
| Active Ingredient: | Darunavir 600mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Nashik, India |
| Product: | DBL™ Cefotaxime Sodium for Injection |
| Active Ingredient: | Cefotaxime sodium 1.048g equivalent to cefotaxime 1g |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Anfarm Hellas SA, Schimatari, Greece ACS Dobfar SpA, Teramo, Italy ACS Dobfar SpA, Verona, Italy |
Dated this 15th day of October 2021.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).