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ACTIVE SUBSTANCE / INN

TRASTUZUMAB

Brand name(s): Trazimera, Herzuma, Tuznue, HERCEPTIN, Zercepac, Ogivri, Kanjinti, Ontruzant, Hervelous, Dazublys, Herceptin, Herwenda
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
AUTHORISED
Breast Neoplasms
Stomach Neoplasms;Breast Neoplasms
ACTIVE SUBSTANCE
Trastuzumab
REGULATORS
FDA · EMA
SPONSORS / MAH
Celltrion Healthcare Hungary Kft., Prestige Biopharma Belgium, Sandoz GmbH
TOTAL APPLICATIONS
13
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
HERCEPTINBLA103792GENENTECHPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
HerceptinRoche Registration GmbHAuthorised28/08/2000Stomach Neoplasms;Breast Neoplasms
OgivriBiosimilar Collaborations Ireland LimitedAuthorised12/12/2018Stomach Neoplasms;Breast Neoplasms
TuznuePrestige Biopharma BelgiumAuthorised19/09/2024Breast Neoplasms
TrazimeraPfizer Europe MA EEIGAuthorised26/07/2018Stomach Neoplasms;Breast Neoplasms
HerzumaCelltrion Healthcare Hungary Kft.Authorised09/02/2018Stomach Neoplasms;Breast Neoplasms
OntruzantSamsung Bioepis NL B.V.Authorised15/11/2017Stomach Neoplasms;Breast Neoplasms
ZercepacAccord Healthcare S.L.U.Authorised27/07/2020Breast Neoplasms;Stomach Neoplasms
HerwendaSandoz GmbHAuthorised15/11/2023Breast Neoplasms;Stomach Neoplasms
DazublysCuraTeQ Biologics s.r.oAuthorised30/06/2025Breast Neoplasms;Stomach Neoplasms
KanjintiAmgen Europe B.V.Authorised16/05/2018Stomach Neoplasms;Breast Neoplasms

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