Consent to the Distribution of New Medicines
Pursuant 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:
| Product: | Kisqali |
| Active Ingredient: | Ribociclib succinate 254.4mg equivalent to ribociclib 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia |
| Product: | Riximyo |
| Active Ingredient: | Rituximab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturers: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia |
| Product: | Zolgensma (8.3mL vial) |
| Active Ingredient: | Onasemnogene abeparvovec 20TVG/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Gene Therapies, Inc., North Carolina, United States of America |
| Product: | Zolgensma (5.5mL vial + 8.3mL vial) |
| Active Ingredient: | Onasemnogene abeparvovec 20TVG/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Gene Therapies, Inc., North Carolina, United States of America |
Dated this 4th day of March 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).