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: | Clindamycin LU |
| Active Ingredient: | Clindamycin hydrochloride 162.868mg equivalent to clindamycin 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Luminarie Group Limited |
| Manufacturer: | Novell Pharmaceutical Laboratories PT., Bogor, Indonesia |
| Product: | Dexdor (200mcg/2mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 118mcg/mL equivalent to dexmedetomidine 100mcg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Orion Pharma (NZ) Limited |
| Manufacturer: | Orion Corporation, Espoo, Finland |
| Product: | Dexdor (400mcg/4mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 118mcg/mL equivalent to dexmedetomidine 100mcg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Orion Pharma (NZ) Limited |
| Manufacturer: | Orion Corporation, Espoo, Finland |
| Product: | Dexdor (1000mcg/10mL) |
| Active Ingredient: | Dexmedetomidine hydrochloride 118mcg/mL equivalent to dexmedetomidine 100mcg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Orion Pharma (NZ) Limited |
| Manufacturer: | Orion Corporation, Espoo, Finland |
| Product: | Flucloxacillin Kabi |
| Active Ingredient: | Flucloxacillin sodium monohydrate 544.1mg equivalent to flucloxacillin 500mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal |
| Product: | Flucloxacillin Kabi |
| Active Ingredient: | Flucloxacillin sodium monohydrate 1088.1mg equivalent to flucloxacillin 1000mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
| Manufacturer: | Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal |
| Product: | Levosimendan ADVZ |
| Active Ingredient: | Levosimendan 2.5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ) |
| Manufacturer: | ONKO ILAC SAN. VE TIC. A.S., Gebze, Turkey |
Dated this 26th day of February 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).