ACTIVE SUBSTANCE / INN

RANIBIZUMAB

Brand name(s): Lucentis, Ranivisio, Ranluspec, Ximluci, Byooviz, LUCENTIS, Susvimo, Rimmyrah, SUSVIMO, Epruvy (previously Ranibizumab Midas)
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
AUTHORISED
Wet Macular Degeneration;Macular Edema;Choroidal Neovascular…
Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;…
ACTIVE SUBSTANCE
Ranibizumab
REGULATORS
FDA · EMA
SPONSORS / MAH
Qilu Pharma Spain S.L., GENENTECH INC, Samsung Bioepis NL B.V.
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LUCENTISBLA125156GENENTECHPrescription
SUSVIMOBLA761197GENENTECH INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ByoovizSamsung Bioepis NL B.V.Authorised18/08/2021Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Myopia, Degenerative
RanluspecLupin Europe GmbHAuthorised10/02/2026Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Diabetes Complicatio…
RimmyrahQilu Pharma Spain S.L.Authorised05/01/2024Wet Macular Degeneration;Macular Edema;Diabetes Complications;Myopia, Degenerati…
LucentisNovartis Europharm LimitedAuthorised22/01/2007Wet Macular Degeneration;Macular Edema;Diabetes Complications;Myopia, Degenerati…
RanivisioMidas Pharma GmbHAuthorised25/08/2022Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Diabetes Complicatio…
Epruvy (previously Ranibizumab Midas)Midas Pharma GmbHAuthorised19/09/2024Wet Macular Degeneration;Macular Edema;Choroidal Neovascularization;Diabetes Com…
XimluciSTADA Arzneimittel AGAuthorised09/11/2022Wet Macular Degeneration;Macular Edema;Diabetic Retinopathy;Diabetes Complicatio…
SusvimoRoche Registration GmbHApplication withdrawnWet Macular Degeneration

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