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ACTIVE SUBSTANCE / INN

NINTEDANIB

Brand name(s): Ofev, Nintedanib Accord, Vargatef, NINTEDANIB, Nintedanib Viatris
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Pu…
Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Pu…
ACTIVE SUBSTANCE
Nintedanib
REGULATORS
FDA · EMA
SPONSORS / MAH
Viatris Limited, APOTEX INC, Accord Healthcare S.L.U.
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NINTEDANIBANDA219227APOTEX INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OfevBoehringer Ingelheim International GmbHAuthorised14/01/2015Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Pulmonary Fibrosis;Scl…
Nintedanib ViatrisViatris LimitedAuthorised22/08/2025Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Pulmonary Fibrosis
Nintedanib AccordAccord Healthcare S.L.U.Authorised19/04/2024Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial;Scleroderma, Systemic;…
VargatefBoehringer Ingelheim International GmbHAuthorised21/11/2014Carcinoma, Non-Small-Cell Lung

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