ACTIVE SUBSTANCE / INN

INDACATEROL;GLYCOPYRRONIUM BROMIDE

Brand name(s): Xoterna Breezhaler, Ulunar Breezhaler, Ultibro Breezhaler
EMA LISTED
AUTHORISED
Pulmonary Disease, Chronic Obstructive
ACTIVE SUBSTANCE
Indacaterol;Glycopyrronium Bromide
REGULATORS
EMA
SPONSORS / MAH
Novartis Europharm Limited
TOTAL APPLICATIONS
3
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Xoterna BreezhalerNovartis Europharm LimitedAuthorised18/09/2013Pulmonary Disease, Chronic Obstructive
Ultibro BreezhalerNovartis Europharm LimitedAuthorised19/09/2013Pulmonary Disease, Chronic Obstructive
Ulunar BreezhalerNovartis Europharm LimitedAuthorised23/04/2014Pulmonary Disease, Chronic Obstructive

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