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: | Histoleve |
| Active Ingredient: | Fluticasone propionate 0.5mg/g |
| Dosage Form: | Nasal spray suspension |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Jewim Pharmaceutical (Shandong) Co., Limited, Shandong Province, China |
| Product: | Nubeqa |
| Active Ingredient: | Darolutamide 300mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | Orion Corporation, Espoo, Finland |
| Product: | Oxycodone HCl (10mg/1mL) (Medicianz) |
| Active Ingredient: | Oxycodone hydrochloride 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Oxycodone HCl (10mg/1mL) (Medsurge) |
| Active Ingredient: | Oxycodone hydrochloride 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Oxycodone HCl (20mg/2mL) (Medicianz) |
| Active Ingredient: | Oxycodone hydrochloride 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Oxycodone HCl (20mg/2mL) (Medsurge) |
| Active Ingredient: | Oxycodone hydrochloride 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Oxycodone HCl (Medicianz) |
| Active Ingredient: | Oxycodone hydrochloride 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Oxycodone HCl (Medsurge) |
| Active Ingredient: | Oxycodone hydrochloride 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
Dated this 9th day of September 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).