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ACTIVE SUBSTANCE / INN

MIRABEGRON

Brand name(s): MIRABEGRON, Betmiga, MYRBETRIQ, MYRBETRIQ GRANULES
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Urinary Bladder, Overactive
NDA202611
ACTIVE SUBSTANCE
Mirabegron
REGULATORS
FDA · EMA
SPONSORS / MAH
APGDI, ALKEM LABS LTD, SAWAI USA
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MIRABEGRONANDA209446SAWAI USADiscontinued
MIRABEGRONANDA215948ALKEM LABS LTDPrescription
MIRABEGRONANDA216757SUNSHINE LAKE PHARMA CO LTDNone (Tentative Approval)
MYRBETRIQNDA202611APGDIPrescription
MYRBETRIQ GRANULESNDA213801APGDIPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
BetmigaAstellas Pharma Europe B.V.Authorised20/12/2012Urinary Bladder, Overactive

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