Notice Type
Departmental
Notice Title

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:

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).