Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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).