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: | Betaferon |
| Active Ingredient: | Interferon beta-1b 0.25mg |
| Dosage Form: | Vial Powder for injection with diluent |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: |
Bayer AG, Berlin, Germany Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany |
| Product: | Ferodan |
| Active Ingredient: | Ferrous sulfate heptahydrate 30mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Odan Laboratories Limited, Quebec, Canada |
| Product: | Synacthen |
| Active Ingredient: | Tetracosactide 0.25mg/mL equivalent to tetracosactide hexaacetate 0.28mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Clinect NZ Pty Limited |
| Manufacturers: | Takeda Austria GmbH, Linz, Austria Delpharm Tours, Chambray Les Tours, France |
| Product: | Synacthen Depot |
| Active Ingredient: | Tetracosactide 1mg/mL equivalent to Tetracosactide hexaacetate 1.12mg/mL |
| Dosage Form: | Injection (depot) |
| New Zealand Sponsor: | Clinect NZ Pty Limited |
| Manufacturers: | Takeda Austria GmbH, St Peter Strasse 25, Linz, Austria Delpharm Tours, Chambray Les Tours, France |
| Product: | Xarelto |
| Active Ingredient: | Rivaroxaban 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | Bayer AG, Leverkusen, Germany Bayer Healthcare Manufacturing Srl, Milano, Italy |
| Product: | Xarelto |
| Active Ingredient: | Rivaroxaban 15mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | Bayer AG, Leverkusen, Germany Bayer Healthcare Manufacturing Srl, Milano, Italy |
| Product: | Xarelto |
| Active Ingredient: | Rivaroxaban 20mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | Bayer AG, Leverkusen, Germany Bayer Healthcare Manufacturing Srl, Milano, Italy |
Dated this 30th day of June 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).