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 set out in the Schedule hereto:
Schedule
| Product: | Leqvio |
| Active Ingredient: | Inclisiran sodium 200mg/mL equivalent to inclisiran 189mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Corden Pharma SpA, Caponago, Italy |
| Product: | Sugammadex Sandoz (200mg/2mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Sugammadex Sandoz (500mg/5mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Sugammadex Viatris (200mg/2mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Hosur, India |
| Product: | Sugammadex Viatris (500mg/5mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Hosur, India |
Dated this 3rd day of April 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).