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ACTIVE SUBSTANCE / INN

TACROLIMUS

Brand name(s): Envarsus, Protopy, Protopic, Modigraf, Advagraf, PROTOPIC, ASTAGRAF XL, PROGRAF, TACROLIMUS, Tacforius, ENVARSUS XR
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
NDA050708
Graft Rejection
ACTIVE SUBSTANCE
Tacrolimus
REGULATORS
FDA · EMA
SPONSORS / MAH
Chiesi Farmaceutici S.p.A., VELOXIS PHARMS INC, HOSPIRA
TOTAL APPLICATIONS
12
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TACROLIMUSANDA090687STRIDES PHARMAPrescription
TACROLIMUSANDA203900HOSPIRADiscontinued
ASTAGRAF XLNDA204096ASTELLASPrescription
PROGRAFNDA050708ASTELLASPrescription
PROTOPICNDA050777LEO PHARMA ASPrescription
ENVARSUS XRNDA206406VELOXIS PHARMS INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ProtopicLEO Pharma A/SAuthorised27/02/2002Dermatitis, Atopic
TacforiusTeva B.V.Authorised08/12/2017Liver Transplantation;Kidney Transplantation
ModigrafAstellas Pharma Europe B.V.Authorised15/05/2009Graft Rejection
EnvarsusChiesi Farmaceutici S.p.A.Authorised18/07/2014Graft Rejection
AdvagrafAstellas Pharma Europe BVAuthorised23/04/2007Graft Rejection
ProtopyAstellas Pharma GmbHWithdrawn28/02/2002Dermatitis, Atopic

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