Consent to the Distribution of New Medicines
Pursuant 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:
| Product: | Aranesp |
| Active Ingredient: | Darbepoetin alfa 25mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (15mcg/0.375mL) |
| Active Ingredient: | Darbepoetin alfa 40mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (20mcg/0.5mL) |
| Active Ingredient: | Darbepoetin alfa 40mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (30mcg/0.3mL) |
| Active Ingredient: | Darbepoetin alfa 100mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (40mcg/0.4mL) |
| Active Ingredient: | Darbepoetin alfa 100mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (50mcg/0.5mL) |
| Active Ingredient: | Darbepoetin alfa 100mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (60mcg/0.3mL) |
| Active Ingredient: | Darbepoetin alfa 200mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (80mcg/0.4mL) |
| Active Ingredient: | Darbepoetin alfa 200mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (100mcg/0.5mL) |
| Active Ingredient: | Darbepoetin alfa 200mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (150mcg/0.3mL) |
| Active Ingredient: | Darbepoetin alfa 500mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (200mcg/0.4mL) |
| Active Ingredient: | Darbepoetin alfa 500mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (300mcg/0.6mL) |
| Active Ingredient: | Darbepoetin alfa 500mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Aranesp (500mcg/1mL) |
| Active Ingredient: | Darbepoetin alfa 500mcg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Amgen Manufacturing Limited, Juncos, Puerto Rico Amgen Technology Ireland, Dun Laoghaire, Ireland |
| Product: | Metrogyl |
| Active Ingredient: | Metronidazole 200mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Alphapharm Pty Limited, Brisbane, Australia |
| Product: | Metrogyl |
| Active Ingredient: | Metronidazole 400mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Alphapharm Pty Limited, Brisbane, Australia |
| Product: | Soliqua SoloStar |
| Active Ingredients: | Insulin glargine 100IU/mL Lixisenatide 0.033mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
| Product: | Soliqua SoloStar |
| Active Ingredients: | Insulin glargine 100IU/mL Lixisenatide 0.05mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany |
Dated this 9th day of July 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).