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: DBL™ Zinc Chloride
Active Ingredient: Zinc chloride 5.3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Siegfried Hameln GmbH, Hameln Germany
   
Product: Herceptin
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
Genentech Inc, Oregon, United States of America
   
Product: Herceptin
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion concentrate with diluent
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
Genentech Inc, California, United States of America
Genentech Inc, Oregon, United States of America
   
Product: Herclon
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
Genentech Inc, Oregon, United States of America
   
Product: Herclon
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion with diluent
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
Genentech Inc, California, United States of America
Genentech Inc, Oregon, United States of America
   
Product: Priadel
Active Ingredient: Lithium carbonate 400mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Clinect NZ Pty Limited
Manufacturer: Delpharm Dijon, Quetigny, France
   
Product: Solu-Medrol
Active Ingredient: Methylprednisolone sodium succinate 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Belgium NV, Puurs, Belgium
Pharmacia & Upjohn Company LLC, Michigan, United States of America
   
Product: Solu-Medrol
Active Ingredient: Methylprednisolone sodium succinate 2g
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Belgium NV, Puurs, Belgium
Pharmacia & Upjohn Company LLC, Michigan, United States of America
   
Product: Solu-Medrol Act-O-Vial
Active Ingredient: Methylprednisolone sodium succinate 40mg/mL
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Belgium NV, Puurs, Belgium
Pharmacia & Upjohn Company LLC, Michigan, United States of America
   
Product: Solu-Medrol Act-O-Vial
Active Ingredient: Methylprednisolone sodium succinate 62.5mg/mL
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Belgium NV, Puurs, Belgium
Pharmacia & Upjohn Company LLC, Michigan, United States of America
   
Product: Solu-Medrol Act-O-Vial
Active Ingredient: Methylprednisolone sodium succinate 728.67mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Belgium NV, Puurs, Belgium
Pharmacia & Upjohn Company LLC, Michigan, United States of America


Dated this 12th day of December 2022.

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