Bioviz epoetin
Epoetin alfa and zeta biosimilar developed by Bioviz Technologies. Reference product Eprex (Epogen and Procrit in the United States).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Bioviz Technologies
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOAug 2011permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Bioviz Technologies Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2011
Application or permission
MF-333/11
Indications as licensed
Anaemia of renal insufficiency, in haemodialysis and non-dialysis patients
Presentations
2,000 and 4,000 IU/mL PFS
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOAug 2011CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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