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: | Hemlibra |
| Active Ingredient: | Emicizumab 30mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya, Japan Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Hemlibra (60mg/0.4mL) |
| Active Ingredient: | Emicizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya, Japan Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Hemlibra (105mg/0.7mL) |
| Active Ingredient: | Emicizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya, Japan Samsung Biologics Co Limited, Incheon, South Korea |
| Product: | Hemlibra (150mg/1mL) |
| Active Ingredient: | Emicizumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturers: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya, Japan Samsung Biologics Co Limited, Incheon, South Korea |
Dated this 22nd day of September 2023.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).