Notice Type
Departmental
Notice Title

Consent to the Distribution of a New Medicine

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:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturer:

Trelegy Ellipta 100/62.5/25
Fluticasone furoate 100mcg
Umeclidinium bromide 74.2mcg equivalent to umeclidinium 62.5mcg (free cation)
Vilanterol trifenatate 40mcg equivalent to vilanterol 25mcg (free base)
Powder for inhalation
GlaxoSmithKline (NZ) Limited
Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Ware, United Kingdom

Dated this 16th day of November 2018.

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