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ACTIVE SUBSTANCE / INN

POMALIDOMIDE

Brand name(s): Imnovid (previously Pomalidomide Celgene), POMALYST, POMALIDOMIDE, Pomalidomide Zentiva, Pomalidomide Krka, Pomalidomide Accord, Pomalidomide Viatris, Pomalidomide Teva
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Multiple Myeloma
ANDA210275
ACTIVE SUBSTANCE
Pomalidomide
REGULATORS
FDA · EMA
SPONSORS / MAH
Teva GmbH, BRISTOL, DR REDDYS LABS LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
POMALIDOMIDEANDA210275MYLANDiscontinued
POMALIDOMIDEANDA213234DR REDDYS LABS LTDNone (Tentative Approval)
POMALIDOMIDEANDA210164APOTEXPrescription
POMALYSTNDA204026BRISTOLPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Pomalidomide TevaTeva GmbHAuthorised14/11/2024Multiple Myeloma
Imnovid (previously Pomalidomide Celgene)Bristol-Myers Squibb Pharma EEIGAuthorised05/08/2013Multiple Myeloma
Pomalidomide KrkaKrka, d.d., Novo mesto Authorised24/07/2024Multiple Myeloma
Pomalidomide ZentivaZentiva, k.s.Authorised24/07/2024Multiple Myeloma
Pomalidomide ViatrisViatris LimitedAuthorised16/02/2024Multiple Myeloma
Pomalidomide AccordAccord Healthcare S.L.U.Authorised26/07/2024Multiple Myeloma

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