Inpremzia
Insulin human biosimilar developed by Baxter. Reference product Humulin (Lilly); Actrapid, Insulatard and Mixtard (Novo Nordisk); Insuman (Sanofi).
Brands by market: Inpremzia (EU, withdrawn) · Commercial partner or holder: Baxter
FDAnot listed
EMAwithdrawn
PMDAnot listed
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Inpremzia
European Medicines Agency and European CommissionWithdrawnBrand
Inpremzia
Holder or applicant
Baxter Holding B.V.
Pathway
Centralised (Article 10(4))
Approved
Apr 2022
Application or permission
EMEA/H/C/005331
Withdrawn
date not published
Presentations
see SmPC
Note
Intravenous ready-to-use human insulin; authorisation withdrawn, date not published in the EMA table.
Source
S017
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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