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: | Nardil |
| Active Ingredient: | Phenelzine sulfate 25.83mg equivalent to phenelzine 15mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Link Pharmaceuticals Limited |
| Manufacturers: | Recipharm Limited, Ashton-Under-Lyne, United Kingdom Haupt Pharma Wulfing GmbH, Gronau, Germany |
| Product: | Praluent |
| Active Ingredient: | Alirocumab 75mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturers: | Sanofi Winthrop Industrie, Le Trait, France Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany Sanofi Pasteur Inc, Pennsylvania, United States of America |
| Product: | Praluent |
| Active Ingredient: | Alirocumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturers: | Sanofi Winthrop Industrie, Le Trait, France Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany |
| Product: | Prolia |
| Active Ingredient: | Denosumab 60mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology (Ireland) Unlimited Company, Dun Laoghaire, Ireland |
Dated this 24th day of February 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).