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: | Actilyse |
| Active Ingredient: | Alteplase 10mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturer: | Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany |
| Product: | Actilyse |
| Active Ingredient: | Alteplase 20mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturer: | Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany |
| Product: | Actilyse |
| Active Ingredient: | Alteplase 50mg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturer: | Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany |
| Product: | Actilyse Cathflo |
| Active Ingredient: | Alteplase 2mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturer: | Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany |
| Product: | Darzalex SC |
| Active Ingredient: | Daratumumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Cilag AG, Schaffhausen, Switzerland |
Dated this 2nd day of April 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).