Grasustek
Pegfilgrastim biosimilar developed by Juta Pharma. Reference product Neulasta.
Brands by market: Grasustek (EU) · Commercial partner or holder: Juta Pharma
FDAnot listed
EMAJun 2019authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Grasustek
European Medicines Agency and European CommissionApprovedBrand
Grasustek
Holder or applicant
Juta Pharma GmbH
Pathway
Centralised (Article 10(4))
Approved
Jun 2019
Application or permission
EMEA/H/C/004556
Presentations
see SmPC
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJun 2019Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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