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Brands by market: Inpremzia (EU, withdrawn) · Commercial partner or holder: Baxter · Company profile
FDANot listed
EMAWithdrawn
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Not yet approved in any of the 7 markets
Connections
About Inpremzia
Inpremzia was Baxter's ready-to-use intravenous human insulin, approved in Europe in April 2022 and later withdrawn without launch. The same product is Myxredlin in Canada and the United States.
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Withdrawn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
Remarks
Intravenous ready-to-use human insulin; authorisation withdrawn, date not published in the EMA table.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom
Not listed by MHRA.
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.
Same developer, other molecules
Other biosimilars in the Atlas developed by Baxter: Axberi, Myxredlin.
Chronology
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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