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: | Bisacodyl-AFT |
| Active Ingredient: | Bisacodyl 5mg |
| Dosage Form: | Enteric coated tablet |
| New Zealand Sponsor: | Neo Pharma Limited |
| Manufacturer: | GPAX Pharmaceuticals Private Limited, Daman, India |
| Product: | Estrogel |
| Active Ingredient: | Estradiol hemihydrate 0.62mg/g equivalent to anhydrous estradiol 0.60mg/g |
| Dosage Form: | Transdermal gel |
| New Zealand Sponsor: | Pharmaco (NZ) Limited |
| Manufacturer: | Besins Manufacturing Belgium, Drogenbos, Belgium |
| Product: | Metronidazole (Medicianz) |
| Active Ingredient: | Metronidazole 5mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | POLIFARMA ILAC SAN.VE. TIC A.S., Tekirdag, Turkey |
| Product: | Metronidazole (Medsurge) |
| Active Ingredient: | Metronidazole 5mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | POLIFARMA ILAC SAN.VE. TIC A.S., Tekirdag, Turkey |
| Product: | Neo Bisacodyl |
| Active Ingredient: | Bisacodyl 5mg |
| Dosage Form: | Enteric coated tablet |
| New Zealand Sponsor: | Neo Pharma Limited |
| Manufacturer: | GPAX Pharmaceuticals Private Limited, Daman, India |
| Product: | Sugammadex-Teva (200mg/2mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
| Product: | Sugammadex-Teva (500mg/5mL) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
| Product: | Tezspire (Pre-filled syringe) |
| Active Ingredient: | Tezepelumab 110mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | Amgen Manufacturing Limited, Juncos, Puerto Rico |
| Product: | Tezspire (Pre-filled Pen) |
| Active Ingredient: | Tezepelumab 110mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | Amgen Manufacturing Limited, Juncos, Puerto Rico |
| Product: | Vildagliptin |
| Active Ingredient: | Vildagliptin 50mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria |
Dated this 13th day of May 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).