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: | 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 |
| 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).