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: | Dabigatran etexilate |
| Active Ingredient: | Dabigatran etexilate mesylate 86.48mg equivalent to dabigatran etexilate 75mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | SAG Manufacturing S.L.U, Madrid, Spain |
| Product: | Dabigatran etexilate |
| Active Ingredient: | Dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | SAG Manufacturing S.L.U, Madrid, Spain |
| Product: | Dabigatran etexilate |
| Active Ingredient: | Dabigatran etexilate mesylate 172.95mg equivalent to dabigatran etexilate 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | SAG Manufacturing S.L.U, Madrid, Spain |
| Product: | Fulvestrant Ever Pharma |
| Active Ingredient: | Fulvestrant 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | EVER Pharma Jena GmbH, Jena, Germany |
| Product: | Midazolam Accord (5mg/mL) |
| Active Ingredient: | Midazolam 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad,India |
| Product: | Midazolam Accord (5mg/5mL) |
| Active Ingredient: | Midazolam 1mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Midazolam Accord (5mg/5mL) (pre-filled syringe) |
| Active Ingredient: | Midazolam 1mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Midazolam Accord (15mg/3mL) |
| Active Ingredient: | Midazolam 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Midazolam Accord (50mg/10mL) |
| Active Ingredient: | Midazolam 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Midazolam Accord (50mg/10mL) (pre-filled syringe) |
| Active Ingredient: | Midazolam 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Tepadina |
| Active Ingredient: | Thiotepa 15mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Link Pharmaceuticals Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina, Italy |
| Product: | Tepadina |
| Active Ingredient: | Thiotepa 100mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Link Pharmaceuticals Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina, Italy |
| Product: | Tepadina |
| Active Ingredient: | Thiotepa 400mg |
| Dosage Form: | Powder for injection |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Link Pharmaceuticals Limited |
| Manufacturer: | NerPharMa SRL, Nerviano, Italy |
Dated this 28th day of July 2023.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).