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Ultibro Breezhaler

85/43 microgram(s) Inhalation Powder, Capsule

Novartis Europharm LimitedEU/1/13/862/001-006

Main Information

Trade NameUltibro Breezhaler
Active SubstancesIndacaterol maleate
Glycopyrronium bromide
Strength85/43 microgram(s)
Dosage FormInhalation Powder, Capsule
Licence HolderNovartis Europharm Limited
Licence NumberEU/1/13/862/001-006

Group Information

ATC CodeR03AL Adrenergics in combination with anticholinergics
R03AL04 indacaterol and glycopyrronium bromide

Status

Authorised/WithdrawnAuthorised
Licence Issued19/09/2013
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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