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: | Creon 20,000 |
| Active Ingredient: | Pancreatin 300mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Abbott Laboratories GmbH, Neustadt, Germany |
| Product: | Creon 35,000 |
| Active Ingredient: | Pancreatin 420mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Abbott Laboratories GmbH, Neustadt, Germany |
| Product: | Metaraminol |
| Active Ingredient: | Metaraminol tartrate 0.95mg/mL equivalent to metaraminol 0.5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Torbay and South Devon NHS Foundation Trust, Paignton, United Kingdom |
| Product: | Noradrenaline |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 0.12mg/mL equivalent to noradrenaline base 0.06mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Product: | Noradrenaline |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 0.199mg/mL equivalent to noradrenaline base 0.1mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Product: | Noradrenaline |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 0.239mg/mL equivalent to noradrenaline base 0.12 mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Product: | Noradrenaline |
| Active Ingredient: | Noradrenaline acid tartrate monohydrate 0.319mg/mL equivalent to noradrenaline base 0.16mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
| Product: | Tenoxicam |
| Active Ingredient: | Tenoxicam 20mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Kartepe, Turkey |
Dated this 13th day of October 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).