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: | 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 |
| Note: The application received 6 January 2020 is for an extension to the metastatic non-small cell lung cancer indication. | |
| 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 |
| Note: The application received 21 February 2020 is for an extension to the hepatocellular carcinoma indication. | |
| 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 |
| Note: The application received 27 May 2020 is for an extension to the metastatic non-small cell lung cancer indication. | |
| 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 |
| Note: The application received 6 January 2020 is for an extension to the metastatic non-small cell lung cancer indication. | |
| 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 |
| Note: The application received 21 February 2020 is for the hepatocellular carcinoma indication. | |
| 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 |
| Note: The application received 27 May 2020 is for an extension to the metastatic non-small cell lung cancer indication. | |
Dated this 5th day of August 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).