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ACTIVE SUBSTANCE / INN

SIROLIMUS

Brand name(s): FYARRO, SIROLIMUS, HYFTOR, Hyftor, Opsiria, Rapamune, RAPAMUNE
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
DISCONTINUED
ANDA215016
NDA213312
ACTIVE SUBSTANCE
Sirolimus
REGULATORS
FDA · EMA
SPONSORS / MAH
PF PRISM CV, DR REDDYS, NOBELPHARMA
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SIROLIMUSANDA201578DR REDDYSPrescription
FYARRONDA213312AADI SUBPrescription
RAPAMUNENDA021083PF PRISM CVPrescription
HYFTORNDA213478NOBELPHARMAPrescription
SIROLIMUSANDA215016TORRENTDiscontinued
RAPAMUNENDA021110PF PRISM CVDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RapamunePfizer Europe MA EEIGAuthorised13/03/2001Graft Rejection;Kidney Transplantation
HyftorPlusultra pharma GmbHAuthorised15/05/2023Angiofibroma;Tuberous Sclerosis
OpsiriaSanten OyApplication withdrawnUveitis

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