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 set out in the Schedule hereto:

Schedule

Product: Abiraterone Devatis
Active Ingredient: Abiraterone acetate 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Bortezomib Ever Pharma (2.5 mg/1 mL)
Active Ingredient: Bortezomib 2.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: EVER Pharma Jena GmbH, Jena, Germany
   
Product: Bortezomib Ever Pharma (3.5 mg/1.4 mL)
Active Ingredient: Bortezomib 2.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: EVER Pharma Jena GmbH, Jena, Germany
   
Product: Hydrocortisone-AFT
Active Ingredient: Hydrocortisone sodium succinate 133.7mg equivalent to hydrocortisone 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: VUAB Pharma A.S, Roztoky, Czech Republic
   
Product: Ketomed
Active Ingredient: Ketorolac trometamol 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Micro Labs Limited, Bangalore, India
   
Product: Ketorolac (Medicianz)
Active Ingredient: Ketorolac trometamol 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Micro Labs Limited, Bangalore, India
   
Product: Ketorolac (Medsurge)
Active Ingredient: Ketorolac trometamol 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Micro Labs Limited, Bangalore, India
   
Product: Parecoxib (Medicianz)
Active Ingredient: Parecoxib sodium 42.36mg equivalent to parecoxib 40mg
Dosage Form: Powder for injection
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Immacule Lifesciences Private Limited, Nalagarh, India
   
Product: Parecoxib (Medsurge)
Active Ingredient: Parecoxib sodium 42.36mg equivalent to parecoxib 40mg
Dosage Form: Powder for injection
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Immacule Lifesciences Private Limited, Nalagarh, India
   
Product: Parecoxib (Medicianz)
Active Ingredient: Parecoxib sodium 42.36mg equivalent to parecoxib 40mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Immacule Lifesciences Private Limited, Nalagarh, India
   
Product: Parecoxib (Medsurge)
Active Ingredient: Parecoxib sodium 42.36mg equivalent to parecoxib 40mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Immacule Lifesciences Private Limited, Nalagarh, India


Dated this 9th day of July 2024.

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