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).