Notice Title

Consent to the Distribution of New Medicines

Publication Date
6 Apr 2023

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2023-go1396
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: Leqvio
Active Ingredient: Inclisiran sodium 200mg/mL equivalent to inclisiran 189mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Corden Pharma SpA, Caponago, Italy
   
Product: Sugammadex Sandoz (200mg/2mL)
Active Ingredient: Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Lek Pharmaceuticals d.d., Ljubljana, Slovenia
   
Product: Sugammadex Sandoz (500mg/5mL)
Active Ingredient: Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Lek Pharmaceuticals d.d., Ljubljana, Slovenia
   
Product: Sugammadex Viatris (200mg/2mL)
Active Ingredient: Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Hosur, India
   
Product: Sugammadex Viatris (500mg/5mL)
Active Ingredient: Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Hosur, India


Dated this 3rd day of April 2023.

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