Notice Title

Consent to the Distribution of New Medicines

Publication Date
7 Jul 2022

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2022-go2780
Title
View PDF
File Type and Size
PDF (38 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: Cabometyx
Active Ingredient: Cabozantinib s-malate 25.34mg equivalent to cabozantinib 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: Cabometyx
Active Ingredient: Cabozantinib s-malate 50.69mg equivalent to cabozantinib 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: Cabometyx
Active Ingredient: Cabozantinib s-malate 76.03mg equivalent to cabozantinib 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Inc, Mississauga, Canada
   
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: PipTaz-AFT
Active Ingredients: Piperacillin monohydrate 4000mg
Tazobactam 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Shandong Anxin Pharmaceutical Co Limited, Jinan, China
   
Product: Tecentriq
Active Ingredient: Atezolizumab 840mg/14mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
   
Product: Tecentriq
Active Ingredient: Atezolizumab 1200mg/20mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland


Dated this 6th day of July 2022.

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