Notice Title

Consent to the Distribution of New Medicines

Publication Date
8 Jun 2023

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2023-go2368
Title
View PDF
File Type and Size
PDF (36 KB)

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: Lithium Carbonate
Active Ingredient: Lithium carbonate 250mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand
   
Product: Opdivo (40mg/4ml)
Active Ingredient: Nivolumab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Opdivo (100mg/10ml)
Active Ingredient: Nivolumab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Soliris
Active Ingredient: Eculizumab 300mg
Dosage Form: Solution for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Patheon Italia S.p.A, Milan, Italy
Alexion Pharma International Operations Unlimited Company, Athlone, Ireland


Dated this 6th day of June 2023.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).