Niopeg
Pegfilgrastim biosimilar developed by Nora Pharma. Reference product Neulasta.
Brands by market: Niopeg (Canada) · Commercial partner or holder: Nora Pharma
FDAnot listed
EMAnot listed
PMDAnot listed
HCApr 2024approved
CDSCOnot listed
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 · Niopeg
Health CanadaApprovedBrand
Niopeg
Holder or applicant
Nora Pharma INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Apr 2024
Application or permission
DIN 02546973
Presentations
6 mg
Source
S022
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- HCApr 2024Notice of Compliance, Health Canada
Sources
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