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: | Calquence |
| Active Ingredient: | Acalabrutinib maleate monohydrate 129mg equivalent to acalabrutinib free base 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AstraZeneca AB, Sodertalje, Sweden |
| Product: | Exarane (20mg/0.2mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China |
| Product: | Exarane (40mg/0.4mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China |
| Product: | Exarane (60mg/0.6mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China |
| Product: | Exarane (80mg/0.8mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China |
| Product: | Exarane (100mg/1mL) |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China |
| Product: | Exarane Forte (120mg/0.8mL) |
| Active Ingredient: | Enoxaparin sodium 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China |
| Product: | Exarane Forte (150mg/1mL) |
| Active Ingredient: | Enoxaparin sodium 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturer: | Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China |
Dated this 18th day of March 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).