Notice Title

Consent to the Distribution of New Medicines

Publication Date
23 Jan 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go309
Title
View PDF
File Type and Size
PDF (36 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: Carboprost-Reach
Active Ingredient: Carboprost trometamol 0.332mg/mL equivalent to carboprost 0.250mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CARSL Consulting
Manufacturer: Immacule Lifesciences Private Limited, Nalagarh, India
   
Product: Dasatinib SUN
Active Ingredient: Dasatinib 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Sun Pharmaceutical Industries Limited, Halol, India
   
Product: Dasatinib SUN
Active Ingredient: Dasatinib 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Sun Pharmaceutical Industries Limited, Halol, India
   
Product: Dasatinib SUN
Active Ingredient: Dasatinib 70mg
Dosage Form: Film coated tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Sun Pharmaceutical Industries Limited, Halol, India
   
Product: Dasatinib SUN
Active Ingredient: Dasatinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Sun Pharmaceutical Industries Limited, Halol, India
   
Product: Rivaroxaban-Teva
Active Ingredient: Rivaroxaban 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Pharmaceutical Industries Limited, Kfar Saba, Israel
   
Product: Rivaroxaban-Teva
Active Ingredient: Rivaroxaban 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Pharmaceutical Industries Limited, Kfar Saba, Israel
   
Product: Rivaroxaban-Teva
Active Ingredient: Rivaroxaban 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Pharmaceutical Industries Limited, Kfar Saba, Israel
   
Product: Rivaroxaban-Teva
Active Ingredient: Rivaroxaban 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Pharmaceutical Industries Limited, Kfar Saba, Israel


Dated this 16th day of January 2025.

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