Notice Title

Consent to the Distribution of a New Medicine

Publication Date
4 Apr 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go1463
Title
View PDF
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 medicine set out in the Schedule hereto:

Schedule

Product: Arexvy
Active Ingredient: Recombinant respiratory syncytial virus pre-fusion F protein 120mcg
Component 1:  
Dosage Form: Powder for injection
Component 2:  
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Biologicals SA (Wave Nord), Wavre, Belgium
GlaxoSmithKline Vaccines SRL, Sovicille, Italy


Dated this 2nd day of April 2024.

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