Valtropin
Somatropin biosimilar developed by BioPartners (LG Life Sciences). Reference product Genotropin (Omnitrope's reference); also Norditropin, Humatrope, Saizen.
Brands by market: Valtropin (EU, withdrawn) · Commercial partner or holder: BioPartners
FDAnot listed
EMAwithdrawn
PMDAnot listed
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Valtropin
European Medicines Agency and European CommissionWithdrawnBrand
Valtropin
Holder or applicant
BioPartners GmbH
Pathway
Centralised (Article 10(4))
Approved
Apr 2006
Application or permission
EMEA/H/C/000602
Withdrawn
May 2012
Presentations
see SmPC
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
- EMAMay 2012Valtropin authorisation withdrawn
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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