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: | Baclofen |
| Active Ingredient: | Baclofen 10mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Noumed Pharmaceuticals Limited |
| Manufacturer: | Adcock Ingram Limited - A Medreich Group Company, Anekal, India |
| Product: | Biomed Fentanyl |
| Active Ingredient: | Fentanyl citrate 15.71mcg/mL equivalent to fentanyl 10mcg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Product: | Biomed Fentanyl |
| Active Ingredient: | Fentanyl citrate 15.71mcg/mL equivalent to fentanyl 10mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Product: | Biomed Fentanyl |
| Active Ingredient: | Fentanyl citrate 31.42mcg/mL equivalent to fentanyl 20mcg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Product: | Carboplatin Accord (50mg/5mL) |
| Active Ingredient: | Carboplatin 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Carboplatin Accord (150mg/15mL) |
| Active Ingredient | Carboplatin 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Carboplatin Accord (450mg/45mL) |
| Active Ingredient: | Carboplatin 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Daptomycin Accord |
| Active Ingredient: | Daptomycin 350mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Daptomycin Accord |
| Active Ingredient: | Daptomycin 500mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Fludrocortisone (Medicianz) |
| Active Ingredient: | Fludrocortisone acetate 0.1mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Adamed Pharma SA, Pabianice, Poland |
| Product: | Fludrocortisone (Medsurge) |
| Active Ingredient: | Fludrocortisone acetate 0.1mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Adamed Pharma SA, Pabianice, Poland |
| Product: | Oxaliplatin |
| Active Ingredient: | Oxaliplatin 5mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Alchemy Health Limited |
| Manufacturer: | Sichuan Huiyu Pharmaceutical Company Limited, Neijiang, China |
| Product: | Rosuvastatin Sandoz |
| Active Ingredient: | Rosuvastatin calcium 5.198mg equivalent to rosuvastatin 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Rosuvastatin Sandoz |
| Active Ingredient: | Rosuvastatin calcium 10.396mg equivalent to rosuvastatin 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Rosuvastatin Sandoz |
| Active Ingredient: | Rosuvastatin calcium 20.791mg equivalent to rosuvastatin 20mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Rosuvastatin Sandoz |
| Active Ingredient: | Rosuvastatin calcium 41.583mg equivalent to rosuvastatin 40mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Teriparatide-Teva |
| Active Ingredient: | Teriparatide 0.25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited., Zagreb, Croatia |
| Product: | Truvelog (cartridge) |
| Active Ingredient: | Insulin aspart 100U/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
| Product: | Truvelog SoloStar (pre-filled pen) |
| Active Ingredient: | Insulin aspart 100U/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
| Product: | Truvelog (vial) |
| Active Ingredient: | Insulin aspart 100U/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
Dated this 12th day of December 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).