Notice Title

Consent to the Distribution of New Medicines

Publication Date
27 Jul 2023

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2023-go3364
Title
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File Type and Size
PDF (35 KB)

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: Rivaroxaban Viatris
Active Ingredient: Rivaroxaban 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Aurangabad, India
   
Product: Rivaroxaban Viatris
Active Ingredient: Rivaroxaban 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Aurangabad, India
   
Product: Rivaroxaban Viatris
Active Ingredient: Rivaroxaban 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Aurangabad, India
   
Product: Zonisamide Te Arai
Active Ingredient: Zonisamide 25mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Cohance Lifesciences Limited, Telangana, India
   
Product: Zonisamide Te Arai
Active Ingredient: Zonisamide 50mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Cohance Lifesciences Limited, Telangana, India
   
Product: Zonisamide Te Arai
Active Ingredient: Zonisamide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Cohance Lifesciences Limited, Telangana, India


Dated this 21st day of July 2023.

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