Lextemy
Bevacizumab biosimilar developed by Mylan (Viatris). Reference product Avastin.
Brands by market: Lextemy (EU, withdrawn) · Commercial partner or holder: Mylan
FDAnot listed
EMAwithdrawn
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Lextemy
European Medicines Agency and European CommissionWithdrawnBrand
Lextemy
Holder or applicant
Mylan IRE Healthcare Limited
Pathway
Centralised (Article 10(4))
Approved
not published
Application or permission
EMEA/H/C/005611
Withdrawn
Jun 2021
Presentations
see SmPC
Note
Withdrawn after opinion, before authorisation.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJun 2021Lextemy authorisation withdrawn
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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