Notice Title

Consent to the Distribution of New Medicines

Publication Date
31 Oct 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go5524
Title
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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: Dabigatran Etexilate Viatris
Active Ingredient: Dabigatran etexilate mesylate 86.475mg equivalent to dabigatran etexilate 75mg
Dosage Form: Capsule
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Chhatrapati Sambhajinagar, India
   
Product: Dabigatran Etexilate Viatris
Active Ingredient: Dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110mg
Dosage Form: Capsule
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Chhatrapati Sambhajinagar, India
   
Product: Dabigatran Etexilate Viatris
Active Ingredient: Dabigatran etexilate mesylate 172.95mg equivalent to dabigatran etexilate 150mg
Dosage Form: Capsule
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Chhatrapati Sambhajinagar, India
   
Product: Skyrizi (180mg/1.2mL) (pre-filled cartridge)
Active Ingredient: Risankizumab 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AbbVie Limited
Manufacturer: Patheon Italia S.p.A, Milan, Italy


Dated this 30th day of October 2024.

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