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Irish Medicines Database · HPRA register

Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules

Authorisation EU/1/20/1441/001-004 · Novartis Europharm Limited

← All medicines
Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules
Licence EU/1/20/1441/001-004 · Unknown
Licence holder
Novartis Europharm Limited (all products →)
Active substances
Indacaterol acetate, Indacaterol, Mometasone furoate
Dosage form
Inhalation powder, hard capsule
Route of administration
Inhalation use
ATC code
R03AK14
First authorised
30/05/2020
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Fixed combination application (Article 10b 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.