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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
| Product: | Contrave 8/90 |
| Active Ingredients: | Bupropion hydrochloride 90mg equivalent to bupropion 78mg Naltrexone hydrochloride 8mg equivalent to naltrexone 7.2mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Patheon Inc, Whitby, Canada |
| Product: | Dexmedetomidine Mylan |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.118mg/mL equivalent to dexmedetomidine 0.100mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Teoranta Limited, Inverin, Ireland |
| Product: | Medical Nitrous Oxide |
| Active Ingredient: | Nitrous oxide 100% |
| Dosage Form: | Gas |
| New Zealand Sponsor: | Air Liquide New Zealand Limited |
| Manufacturers: | Air Liquide New Zealand Limited, Auckland, New Zealand BOC Limited, Auckland, New Zealand |
| Product: | Mvasi (100mg/4mL) |
| Active Ingredient: | Bevacizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Patheon Manufacturing Services LLC, North Carolina, United States of America Amgen Manufacturing Limited, Juncos, Puerto Rico |
| Note: The application received 14 May 2021 is for the finished product changes | |
| Product: | Mvasi (400mg/16mL) |
| Active Ingredient: | Bevacizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Patheon Manufacturing Services LLC, North Carolina, United States of America Amgen Manufacturing Limited, Juncos, Puerto Rico |
| Note: The application received 14 May 2021 is for the finished product changes | |
| Product: | Mvasi (100mg/4mL) |
| Active Ingredient: | Bevacizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Patheon Manufacturing Services LL, North Carolina, United States of America Amgen Manufacturing Limited, Juncos, Puerto Rico |
| Note: The application received 30 June 2021 is for the active ingredient changes | |
| Product: | Mvasi (400mg/16mL) |
| Active Ingredient: | Bevacizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturers: | Patheon Manufacturing Services LLC, North Carolina, United States of America Amgen Manufacturing Limited, Juncos, Puerto Rico |
| Note: The application received 30 June 2021 is for the active ingredient changes | |
Dated this 9th day of August 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).