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ACTIVE SUBSTANCE / INN

SOMATROPIN

Brand name(s): SEROSTIM, ACCRETROPIN, ZOMACTON, BIO-TROPIN, SAIZEN, NutropinAq, Valtropin, SEROSTIM LQ, HUMATROPE, Somatropin Biopartners, Omnitrope
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
BLA021538
BLA019764
ACTIVE SUBSTANCE
Somatropin
REGULATORS
FDA · EMA
SPONSORS / MAH
Ipsen Pharma, Sandoz GmbH, FERRING
TOTAL APPLICATIONS
14
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SAIZENBLA019764EMD SERONOPrescription
SAIZENBLA019764EMD SERONODiscontinued
ACCRETROPINBLA021538EMERGENTDiscontinued
HUMATROPEBLA019640LILLYDiscontinued
HUMATROPEBLA019640LILLYPrescription
ZOMACTONBLA019774FERRINGPrescription
BIO-TROPINBLA019774FERRINGDiscontinued
SEROSTIMBLA020604EMD SERONOPrescription
SEROSTIMBLA020604EMD SERONODiscontinued
SEROSTIM LQBLA020604EMD SERONODiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OmnitropeSandoz GmbHAuthorised12/04/2006Turner Syndrome;Prader-Willi Syndrome;Dwarfism, Pituitary
NutropinAqIpsen PharmaAuthorised15/02/2001Turner Syndrome;Dwarfism, Pituitary
Somatropin BiopartnersBioPartners GmbHLapsed05/08/2013Growth
ValtropinBioPartners GmbHWithdrawn24/04/2006Turner Syndrome;Dwarfism, Pituitary

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