Notice Title

Consent to the Distribution of New Medicines

Publication Date
21 Mar 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go1219
Title
View PDF
File Type and Size
PDF (37 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: Calquence
Active Ingredient: Acalabrutinib maleate monohydrate 129mg equivalent to acalabrutinib free base 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
   
Product: Exarane (20mg/0.2mL)
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China
   
Product: Exarane (40mg/0.4mL)
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China
   
Product: Exarane (60mg/0.6mL)
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China
   
Product: Exarane (80mg/0.8mL)
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China
   
Product: Exarane (100mg/1mL)
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China
   
Product: Exarane Forte (120mg/0.8mL)
Active Ingredient: Enoxaparin sodium 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China
   
Product: Exarane Forte (150mg/1mL)
Active Ingredient: Enoxaparin sodium 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Juno Pharmaceuticals NZ Limited
Manufacturer: Shenzhen Techdow Pharmaceutical Co., Limited, Shenzhen City, China


Dated this 18th day of March 2024.

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