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Irish Medicines Database · HPRA register

Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed

Authorisation EU/1/17/1174/001-003 · GlaxoSmithKline Trading Services Limited

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Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
Licence EU/1/17/1174/001-003 · Unknown
Licence holder
GlaxoSmithKline Trading Services Limited (all products →)
Active substance
Umeclidinium bromide
Dosage form
Inhalation powder, pre-dispensed
Route of administration
Inhalation use
ATC code
R03BB07
First authorised
20/03/2017
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Informed consent application (Article 10c of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.