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ACTIVE SUBSTANCE / INN

LENALIDOMIDE

Brand name(s): Revlimid, Lenalidomide Accord, LENALIDOMIDE, Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka), Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto), Lenalidomide Mylan, Lenalidomide Krka d.d., REVLIMID, Lenalidomide Celgene Europe
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
Multiple Myeloma
Multiple Myeloma;Lymphoma, Follicular
ACTIVE SUBSTANCE
Lenalidomide
REGULATORS
FDA · EMA
SPONSORS / MAH
Krka, d.d., Novo mesto , Mylan Ireland Limited, BRISTOL MYERS SQUIBB
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LENALIDOMIDEANDA214618CIPLAPrescription
REVLIMIDNDA021880BRISTOL MYERS SQUIBBPrescription
LENALIDOMIDEANDA213405TORRENTDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)Krka, d.d., Novo mesto Authorised11/02/2021Multiple Myeloma;Myelodysplastic Syndromes;Lymphoma, Follicular;Lymphoma, Mantle…
Lenalidomide AccordAccord Healthcare S.L.U.Authorised20/09/2018Multiple Myeloma
Lenalidomide MylanMylan Ireland LimitedAuthorised18/12/2020Multiple Myeloma
RevlimidBristol-Myers Squibb Pharma EEIGAuthorised14/06/2007Multiple Myeloma;Lymphoma, Mantle-Cell;Myelodysplastic Syndromes
Lenalidomide Krka d.d.Krka, d.d., Novo mesto Withdrawn11/02/2021Multiple Myeloma;Lymphoma, Follicular;Myelodysplastic Syndromes
Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)Krka, d.d., Novo mesto Authorised11/02/2021Multiple Myeloma;Lymphoma, Follicular
Lenalidomide Celgene EuropeCelgene Europe LimitedApplication withdrawnMyelodysplastic Syndromes

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