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:
Schedule
Product: | Cetrotide |
Active Ingredient: | Cetrorelix acetate 0.26mg |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
Manufacturers: | Baxter Oncology GmbH, Westfalen, Germany Pierre Fabre Medicament Production, Idron, France |
Product: | Hydralyte™ Apple Blackcurrant Effervescent Electrolyte Tablets |
Active Ingredients: | Citric acid 672mg Glucose 1620mg Potassium chloride 149mg Sodium bicarbonate 378mg Sodium chloride 87.5mg |
Dosage Form: | Effervescent tablet |
New Zealand Sponsor: | CARSL Consulting |
Manufacturers: | Alpex Pharma SA, Mezzovico, Switzerland C Hedenkamp GmbH & Co KG, Hovelhof, Germany |
Product: | Hydralyte™ Orange Effervescent Electrolyte Tablets |
Active Ingredients: | Citric acid 672mg Glucose 1620mg Potassium chloride 149mg Sodium bicarbonate 378mg Sodium chloride 87.5mg |
Dosage Form: | Effervescent tablet |
New Zealand Sponsor: | CARSL Consulting |
Manufacturers: | Alpex Pharma SA, Mezzovico, Switzerland C Hedenkamp GmbH & Co KG, Hovelhof, Germany |
Product: | Opdivo |
Active Ingredient: | Nivolumab 47mg equivalent to 40mg/4mL |
Dosage Form: | Concentrate for infusion |
New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
Manufacturers: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
Product: | Opdivo |
Active Ingredient: | Nivolumab 107mg equivalent to 100mg/10mL |
Dosage Form: | Concentrate for infusion |
New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
Manufacturers: | Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
Product: | PiperTaz Sandoz |
Active Ingredients: | Piperacillin monohydrate 4.198g equivalent to piperacillin sodium 4.2531g equivalent to piperacillin 4.0g Tazobactam 0.5g equivalent to tazobactam sodium 0.54733g |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Sandoz GmbH, Kundl, Austria |
Note: This consent is valid to 8 June 2020 | |
Product: | PipTaz Sandoz |
Active Ingredients: | Piperacillin monohydrate 4.198g equivalent to piperacillin sodium 4.2531g equivalent to piperacillin 4.0g Tazobactam 0.5g equivalent to Tazobactam sodium 0.54733 g |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Sandoz GmbH, Kundl, Austria |
Dated this 23rd day of March 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).