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: No Doz
Active Ingredient: Caffeine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Wilson Foods Limited
Manufacturers: Cipla Limited, District Raigad, India
Mega Lifesciences (Australia) Pty Limited, Melbourne, Australia
   
Product: Opdivo (40mg/4mL)
Active Ingredient: Nivolumab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Opdivo (100mg/10mL)
Active Ingredient: Nivolumab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Winglore (50mg/10mL)
Active Ingredient: Ipilimumab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Winglore (200mg/40mL)
Active Ingredient: Ipilimumab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Yervoy (50mg/10mL)
Active Ingredient: Ipilimumab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   
Product: Yervoy ((200mg/40mL)
Active Ingredient: Ipilimumab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
   

Product:
Zerbaxa
Active Ingredients: Ceftolozane sulfate 1147mg equivalent to ceftolozane 1000mg
Tazobactam sodium 537mg equivalent to tazobactam 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Steri-Pharma LLC, New York, United States of America


Dated this 9th day of February 2024.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).