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: | Alburex 5 NZ (12.5g/250mL) |
| Active Ingredient: | Albumin 50mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring (Australia) Pty Limited, Melbourne, Australia |
| Product: | Alburex 5 NZ (25g/500mL) |
| Active Ingredient: | Albumin 50mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring (Australia) Pty Limited, Melbourne, Australia |
| Product: | Droperidol (Medicianz) |
| Active Ingredient: | Droperidol 1.25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Droperidol (Medsurge) |
| Active Ingredient: | Droperidol 1.25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Droperidol (Medicianz) |
| Active Ingredient: | Droperidol 2.5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Droperidol (Medsurge) |
| Active Ingredient: | Droperidol 2.5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Phentermine Juno ER |
| Active Ingredient: | Phentermine hydrochloride 18.6375mg equivalent to Phentermine 15mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturers: | Konapharma AG, Pratteln, Switzerland Alpex Pharma SA, Mezzovico, Switzerland |
| Product: | Phentermine Juno ER |
| Active Ingredient: | Phentermine hydrochloride 37.275mg equivalent to Phentermine 30mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturers: | Konapharma AG, Pratteln, Switzerland Alpex Pharma SA, Mezzovico, Switzerland |
| Product: | Polivy |
| Active Ingredient: | Polatuzumab vedotin 30mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | F Hoffmann-La Roche AG, Kaiseraugst, Switzerland |
| Product: | Supremine |
| Active Ingredient: | Phentermine hydrochloride 18.6375mg equivalent to Phentermine 15mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturers: | Konapharma AG, Pratteln, Switzerland Alpex Pharma SA, Mezzovico, Switzerland |
| Product: | Supremine |
| Active Ingredient: | Phentermine hydrochloride 37.275mg equivalent to Phentermine 30mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
| Manufacturers: | Konapharma AG, Pratteln, Switzerland Alpex Pharma SA, Mezzovico, Switzerland |
Dated this 8th day of December 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).