Thorinane
Enoxaparin sodium biosimilar developed by Pharmathen. Reference product Clexane (Lovenox in the United States).
Brands by market: Thorinane (EU, lapsed) · Commercial partner or holder: Pharmathen
FDAnot listed
EMAwithdrawn
PMDAnot listed
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Thorinane
European Medicines Agency and European CommissionWithdrawnBrand
Thorinane
Holder or applicant
Pharmathen S.A.
Pathway
Centralised (Article 10(4))
Approved
Sep 2016
Application or permission
EMEA/H/C/003795
Withdrawn
Sep 2019
Presentations
see SmPC
Note
Authorisation lapsed 15 September 2019.
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
- EMASep 2019Thorinane authorisation withdrawn
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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