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ACTIVE SUBSTANCE / INN

THIOTEPA

Brand name(s): THIOTEPA, Tepadina, TEPADINA, TEPYLUTE, TEPADINA AND SODIUM CHLORIDE, Thiotepa Riemser, THIOPLEX
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA209150
Hematopoietic Stem Cell Transplantation
ACTIVE SUBSTANCE
Thiotepa
REGULATORS
FDA · EMA
SPONSORS / MAH
HENGRUI PHARMA, SHORLA, ADIENNE S.r.l. S.U.
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
THIOTEPAANDA209150HENGRUI PHARMAPrescription
THIOTEPANDA011683IMMUNEXDiscontinued
TEPADINA AND SODIUM CHLORIDENDA208264ADIENNE SAPrescription
TEPADINANDA208264ADIENNE SAPrescription
TEPYLUTENDA216984SHORLAPrescription
THIOPLEXNDA020058IMMUNEXDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TepadinaADIENNE S.r.l. S.U.Authorised15/03/2010Hematopoietic Stem Cell Transplantation
Thiotepa RiemserEsteve Pharmaceuticals GmbHAuthorised26/03/2021Hematopoietic Stem Cell Transplantation;Neoplasms

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