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: | Abiraterone - Teva |
| Active Ingredient: | Abiraterone acetate 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Industries Limited, Kfar Saba, Israel |
| Product: | AdiraMedica Paracetamol 500mg and Caffeine 65mg (General sale) |
| Active Ingredients: | Caffeine 65mg Paracetamol 500mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturer: | Softgel Healthcare Pvt. Limited, Pudupakkam Village, India |
| Product: | AdiraMedica Paracetamol 500mg and Caffeine 65mg (Pharmacy only) |
| Active Ingredients: | Caffeine 65mg Paracetamol 500mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturer: | Softgel Healthcare Pvt. Limited, Pudupakkam Village, India |
| 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., Illinois, 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., Illinois, United States of America |
Dated this 7th day of February 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).