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ACTIVE SUBSTANCE / INN

ACLIDINIUM BROMIDE

Brand name(s): Bretaris Genuair, Eklira Genuair, TUDORZA PRESSAIR, DUAKLIR PRESSAIR
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Pulmonary Disease, Chronic Obstructive
NDA210595
ACTIVE SUBSTANCE
Aclidinium Bromide
REGULATORS
FDA · EMA
SPONSORS / MAH
COVIS, Covis Pharma Europe B.V.
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TUDORZA PRESSAIRNDA202450COVISPrescription
DUAKLIR PRESSAIRNDA210595COVISPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Eklira GenuairCovis Pharma Europe B.V.Authorised20/07/2012Pulmonary Disease, Chronic Obstructive
Bretaris GenuairCovis Pharma Europe B.V.Authorised20/07/2012Pulmonary Disease, Chronic Obstructive

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