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ACTIVE SUBSTANCE / INN

NIVOLUMAB

Brand name(s): Nivolumab BMS, OPDIVO QVANTIG, OPDIVO, OPDUALAG, Opdivo
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
AUTHORISED
BLA761381
Melanoma;Hodgkin Disease;Carcinoma, Renal Cell;Carcinoma, No…
ACTIVE SUBSTANCE
Nivolumab
REGULATORS
FDA · EMA
SPONSORS / MAH
BRISTOL-MYERS SQUIBB, Bristol-Myers Squibb Pharma EEIG, BRISTOL MYERS SQUIBB
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
OPDIVO QVANTIGBLA761381BRISTOL-MYERS SQUIBBPrescription
OPDUALAGBLA761234BRISTOL MYERS SQUIBBPrescription
OPDIVOBLA125527BRISTOL MYERS SQUIBBPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OpdivoBristol-Myers Squibb Pharma EEIGAuthorised19/06/2015Melanoma;Hodgkin Disease;Carcinoma, Renal Cell;Carcinoma, Non-Small-Cell Lung;Ca…
Nivolumab BMSBristol-Myers Squibb Pharma EEIGWithdrawn20/07/2015Carcinoma, Non-Small-Cell Lung

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