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ACTIVE SUBSTANCE / INN

PACLITAXEL

Brand name(s): Naveruclif, Apealea, Abraxane, TAXOL, Pazenir, Apexelsin, Paxene, ABRAXANE, PACLITAXEL
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
Breast Neoplasms
Ovarian Neoplasms
ACTIVE SUBSTANCE
Paclitaxel
REGULATORS
FDA · EMA
SPONSORS / MAH
AM REGENT, HQ SPCLT PHARMA, Whiteoak Pharmaceutical B.V.
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PACLITAXELNDA211875AM REGENTPrescription
PACLITAXELANDA075297TEVA PHARMS USADiscontinued
ABRAXANENDA021660BRISTOL-MYERSPrescription
TAXOLNDA020262HQ SPCLT PHARMADiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AbraxaneBristol-Myers Squibb Pharma EEIGAuthorised11/01/2008Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung
NaveruclifAccord Healthcare S.L.U.Authorised05/01/2024Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung
Pazenirratiopharm GmbHAuthorised06/05/2019Breast Neoplasms
ApexelsinWhiteoak Pharmaceutical B.V.Authorised24/07/2024Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung
ApealeaInceptua ABWithdrawn20/11/2018Ovarian Neoplasms
PaxeneNorton Healthcare Ltd.Withdrawn19/07/1999Sarcoma, Kaposi;Carcinoma, Non-Small-Cell Lung;Ovarian Neoplasms;Breast Neoplasm…

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