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: | Darzalex (100mg/5mL) |
| Active Ingredient: | Daratumumab 20mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Cilag AG, Schaffhausen, Switzerland |
| Product: | Darzalex (400mg/20mL) |
| Active Ingredient: | Daratumumab 20mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Cilag AG, Schaffhausen, Switzerland |
| Product: | Jardiance |
| Active Ingredient: | Empagliflozin 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ Limited) |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany Boehringer Ingelheim Hellas Single Member S.A., Koropi Attiki, Greece Boehringer Ingelheim Seiyaku Co. Limited, Higashine, Japan |
| Note: The application received 9 January 2023 | |
| Product: | Jardiance |
| Active Ingredient: | Empagliflozin 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany Boehringer Ingelheim Hellas Single Member S.A., Koropi Attiki, Greece Boehringer Ingelheim Seiyaku Co. Limited, Higashine, Japan |
| Note: The application received 9 January 2023 | |
| Product: | Jardiance |
| Active Ingredient: | Empagliflozin 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany Boehringer Ingelheim Hellas Single Member S.A., Koropi Attiki, Greece Boehringer Ingelheim Seiyaku Co. Limited, Higashine, Japan |
| Note: The application received 28 April 2023 | |
| Product: | Jardiance |
| Active Ingredient: | Empagliflozin 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany Boehringer Ingelheim Hellas Single Member S.A., Koropi Attiki, Greece Boehringer Ingelheim Seiyaku Co. Limited, Higashine, Japan |
| Note: The application received 28 April 2023 | |
Dated this 17th day of November 2023
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).