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ACTIVE SUBSTANCE / INN

TEDUGLUTIDE

Brand name(s): GATTEX KIT, Teduglutide Viatris, Revestive
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Malabsorption Syndromes
Short Bowel Syndrome
ACTIVE SUBSTANCE
Teduglutide
REGULATORS
FDA · EMA
SPONSORS / MAH
TAKEDA PHARMS USA, Viatris Limited, Takeda Pharmaceuticals International AG Ireland
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
GATTEX KITNDA203441TAKEDA PHARMS USAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Teduglutide ViatrisViatris LimitedAuthorised08/01/2026Short Bowel Syndrome
RevestiveTakeda Pharmaceuticals International AG IrelandAuthorised30/08/2012Malabsorption Syndromes

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