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: | DBL™ Carboplatin Injection |
Active Ingredient: | Carboplatin 10mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Pfizer New Zealand Limited |
Manufacturer: | Hospira Australia Pty Limited, Melbourne, Australia |
Product: | Lynparza |
Active Ingredient: | Olaparib 100mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AstraZeneca Limited |
Manufacturers: | AstraZeneca AB, Sodertalje, Sweden AbbVie Limited, Barceloneta, Puerto Rico AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany |
Product: | Lynparza |
Active Ingredient: | Olaparib 150mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AstraZeneca Limited |
Manufacturers: | AstraZeneca AB, Sodertalje, Sweden AbbVie Limited, Barceloneta, Puerto Rico AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany |
Product: | Sugammadex Juno (200mg/2mL) |
Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
Manufacturer: | Lupin Limited, Nagpur, India |
Product: | Sugammadex Juno (500mg/5mL) |
Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
Manufacturer: | Lupin Limited, Nagpur, India |
Dated this 11th day of September 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).