ACTIVE SUBSTANCE / INN

TOPOTECAN

Brand name(s): Topotecan Eagle, Topotecan Actavis, Potactasol, Evotopin, Hycamtin, Topotecan SUN, Topotecan Hospira, Topotecan Teva
EMA LISTED
APPLICATION WITHDRAWN
WITHDRAWN
AUTHORISED
Ovarian Neoplasms;Uterine Cervical Neoplasms;Small Cell Lung…
Ovarian Neoplasms
ACTIVE SUBSTANCE
Topotecan
REGULATORS
EMA
SPONSORS / MAH
Sandoz Pharmaceuticals d.d., Sun Pharmaceutical Industries Europe B.V., Pfizer Europe MA EEIG
TOTAL APPLICATIONS
8
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
HycamtinSandoz Pharmaceuticals d.d.Authorised12/11/1996Ovarian Neoplasms;Uterine Cervical Neoplasms;Small Cell Lung Carcinoma
Topotecan HospiraPfizer Europe MA EEIGAuthorised09/06/2010Uterine Cervical Neoplasms;Small Cell Lung Carcinoma
PotactasolActavis Group PTC ehfAuthorised06/01/2011Uterine Cervical Neoplasms;Small Cell Lung Carcinoma
Topotecan ActavisActavis Group PTC ehfWithdrawn24/07/2009Uterine Cervical Neoplasms;Small Cell Lung Carcinoma
Topotecan TevaTeva B.V.Withdrawn21/09/2009Ovarian Neoplasms;Uterine Cervical Neoplasms;Small Cell Lung Carcinoma
Topotecan EagleEagle Laboratories Ltd.   Withdrawn22/12/2011Carcinoma;Small Cell Lung Carcinoma
Topotecan SUNSun Pharmaceutical Industries Europe B.V.Application withdrawn
EvotopinBeecham Group plcWithdrawn15/04/1997Ovarian Neoplasms

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