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: Darzalex (100mg/5mL)
Active Ingredient: Daratumumab 20mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Cilag AG, Schaffhausen, Switzerland
   
Product: Darzalex (400mg/20mL)
Active Ingredient: Daratumumab 20mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Cilag AG, Schaffhausen, Switzerland
   
Product: Jardiance
Active Ingredient: Empagliflozin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ Limited)
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Boehringer Ingelheim Hellas Single Member S.A., Koropi Attiki, Greece
Boehringer Ingelheim Seiyaku Co. Limited, Higashine, Japan
Note: The application received 9 January 2023
   
Product: Jardiance
Active Ingredient: Empagliflozin 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Boehringer Ingelheim Hellas Single Member S.A., Koropi Attiki, Greece
Boehringer Ingelheim Seiyaku Co. Limited, Higashine, Japan
Note: The application received 9 January 2023
   
Product: Jardiance
Active Ingredient: Empagliflozin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Boehringer Ingelheim Hellas Single Member S.A., Koropi Attiki, Greece
Boehringer Ingelheim Seiyaku Co. Limited, Higashine, Japan
Note: The application received 28 April 2023
   
Product: Jardiance
Active Ingredient: Empagliflozin 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Boehringer Ingelheim Hellas Single Member S.A., Koropi Attiki, Greece
Boehringer Ingelheim Seiyaku Co. Limited, Higashine, Japan
Note: The application received 28 April 2023


Dated this 17th day of November 2023

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