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 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:
| Product: | Daktarin Pressurised Spray |
| Active Ingredient: | Miconazole nitrate 0.16%w/w equivalent to miconazole nitrate dry powder 2%w/w |
| Dosage Form: | Topical spray powder |
| New Zealand Sponsor: | JNTL Consumer Health (New Zealand) Limited |
| Manufacturer: | Ensign Laboratories Pty Limited, Melbourne, Australia |
| Product: | Demazin 12 Hour Nasal Decongestant Spray |
| Active Ingredient: | Oxymetazoline hydrochloride 0.5mg/mL |
| Dosage Form: | Nasal spray solution |
| New Zealand Sponsor: | Noumed Pharmaceuticals Limited |
| Manufacturer: | Probiotec Pharma Pty Limited, Melbourne, Australia |
| Product: | Levosert |
| Active Ingredient: | Levonorgestrel 52mg |
| Dosage Form: | Intrauterine contraceptive device |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturer: | Odyssea Pharma S.A., Grace-Hollogne, Belgium |
| Product: | Sleep Safe Balance 1.5% glucose, 1.25mmol/L Ca |
| Active Ingredients: | Calcium chloride dihydrate 0.1838g/L Glucose monohydrate 16.5g/L equivalent to glucose anhydrous 15g/L Magnesium chloride hexahydrate 0.1017g/L Sodium chloride 5.64g/L Sodium lactate 3.925g/L |
| Dosage Form: | Dialysis solution |
| New Zealand Sponsor: | Maxx Pharma NZ Limited |
| Manufacturers: | Fresenius Medical Care Deutschland GmbH, St Wendel, Germany Fresenius Medical Care Japan KK, Buzen-shi, Japan |
| Note: | Applications were received 10 November 2021 and 14 February 2023 |
| Product: | Sleep Safe Balance 2.3% glucose, 1.25mmol/L Ca |
| Active Ingredients: | Calcium chloride dihydrate 0.1838g/L Glucose monohydrate 25g/L equivalent to glucose anhydrous 22.73g/L Magnesium chloride hexahydrate 0.1017g/L Sodium chloride 5.64g/L Sodium lactate 3.925g/L |
| Dosage Form: | Dialysis solution |
| New Zealand Sponsor: | Maxx Pharma NZ Limited |
| Manufacturers: | Fresenius Medical Care Deutschland GmbH, St Wendel, Germany Fresenius Medical Care Japan KK, Buzen-shi, Japan |
| Note: | Applications were received 10 November 2021 and 14 February 2023 |
| Product: | Sleep Safe Balance 4.25% glucose, 1.25mmol/L Ca |
| Active Ingredients: | Calcium chloride dihydrate 0.1838g/L Glucose monohydrate 46.75g/L Magnesium chloride hexahydrate 0.1017g/L Sodium chloride 5.64g/L Sodium lactate 3.925g/L |
| Dosage Form: | Dialysis solution |
| New Zealand Sponsor: | Maxx Pharma NZ Limited |
| Manufacturers: | Fresenius Medical Care Deutschland GmbH, St Wendel, Germany Fresenius Medical Care Japan KK, Buzen-shi, Japan |
| Note: | Applications were received 10 November 2021 and 14 February 2023 |
| Product: | Stay Safe Balance 1.5% glucose, 1.25mmol/L Ca |
| Active Ingredients: | Calcium chloride dihydrate 0.1838g/L Glucose monohydrate 16.5g/L equivalent to glucose anhydrous 15g/L Magnesium chloride hexahydrate 0.1017g/L Sodium chloride 5.64g/L Sodium lactate 3.925g/L |
| Dosage Form: | Dialysis solution |
| New Zealand Sponsor: | Maxx Pharma NZ Limited |
| Manufacturers: | Fresenius Medical Care Deutschland GmbH, St Wendel, Germany Fresenius Medical Care Japan KK, Buzen-shi, Japan |
| Note: | Applications were received 10 November 2021 and 14 February 2023 |
| Product: | Stay Safe Balance 2.3% glucose, 1.25mmol/L Ca |
| Active Ingredients: | Calcium chloride dihydrate 0.1838g/L Glucose monohydrate 25g/L equivalent to glucose anhydrous 22.73g/L Magnesium chloride hexahydrate 0.1017g/L Sodium chloride 5.64g/L Sodium lactate 3.925g/L |
| Dosage Form: | Dialysis solution |
| New Zealand Sponsor: | Maxx Pharma NZ Limited |
| Manufacturers: | Fresenius Medical Care Deutschland GmbH, St Wendel, Germany Fresenius Medical Care Japan KK, Buzen-shi, Japan |
| Note: | Applications were received 10 November 2021 and 14 February 2023 |
| Product: | Stay Safe Balance 4.25% glucose, 1.25mmol/L Ca |
| Active Ingredients: | Calcium chloride dihydrate 0.1838g/L Glucose monohydrate 46.75g/L equivalent to glucose anhydrous 42.5g/L Magnesium chloride hexahydrate 0.1017g/L Sodium chloride 5.64g/L Sodium lactate 3.925g/L |
| Dosage Form: | Dialysis solution |
| New Zealand Sponsor: | Maxx Pharma NZ Limited |
| Manufacturers: | Fresenius Medical Care Deutschland GmbH, St Wendel, Germany Fresenius Medical Care Japan KK, Buzen-shi, Japan |
| Note: | Applications were received 10 November 2021 and 14 February 2023 |
Dated this 14th day of April 2025.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).