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ACTIVE SUBSTANCE / INN

AFATINIB

Brand name(s): Giotrif, AFATINIB
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Carcinoma, Non-Small-Cell Lung
ANDA210703
ACTIVE SUBSTANCE
Afatinib
REGULATORS
FDA · EMA
SPONSORS / MAH
SANDOZ INC, Boehringer Ingelheim International GmbH
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AFATINIBANDA210703SANDOZ INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
GiotrifBoehringer Ingelheim International GmbHAuthorised25/09/2013Carcinoma, Non-Small-Cell Lung

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