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ACTIVE SUBSTANCE / INN

GEMTUZUMAB OZOGAMICIN

Brand name(s): Mylotarg, MYLOTARG
FDA LISTED
EMA LISTED
PRESCRIPTION
REFUSED
AUTHORISED
BLA761060
Leukemia, Myeloid, Acute
ACTIVE SUBSTANCE
Gemtuzumab Ozogamicin
REGULATORS
FDA · EMA
SPONSORS / MAH
WYETH PHARMS INC, Pfizer Europe MA EEIG, Wyeth Europa Ltd
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MYLOTARGBLA761060WYETH PHARMS INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
MylotargPfizer Europe MA EEIGAuthorised19/04/2018Leukemia, Myeloid, Acute
MylotargWyeth Europa LtdRefusedLeukemia, Myeloid, Acute

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