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ACTIVE SUBSTANCE / INN

INSULIN HUMAN

Brand name(s): Solumarv, Insulin Human 30/70 Mix Marvel, MYXREDLIN, Insuman, HUMULIN R KWIKPEN, Isomarv medium, Exubera, Insulin Human Winthrop, Insulin Human Rechon, HUMULIN R, Combimarv, Insulin Human Long Marvel, Insulin Human Rapid Marvel
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
APPLICATION WITHDRAWN
BLA208157
BLA018780
ACTIVE SUBSTANCE
Insulin Human
REGULATORS
FDA · EMA
SPONSORS / MAH
BAXTER HLTHCARE CORP, Marvel LifeSciences Ltd., sanofi-aventis Deutschland GmbH
TOTAL APPLICATIONS
14
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MYXREDLINBLA208157BAXTER HLTHCARE CORPPrescription
HUMULIN RBLA018780LILLYPrescription
HUMULIN R KWIKPENBLA018780LILLYPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
InsumanSanofi-aventis Deutschland GmbHAuthorised21/02/1997Diabetes Mellitus
Insulin Human RechonRechon Life Science ABApplication withdrawnDiabetes Mellitus
Insulin Human Winthropsanofi-aventis Deutschland GmbHWithdrawn17/01/2007Diabetes Mellitus
SolumarvMarvel Lifesciences LtdRefusedDiabetes Mellitus
SolumarvMarvel Life Sciences Ltd.Application withdrawn—
Isomarv mediumMarvel Life Sciences Ltd.Application withdrawn—
CombimarvMarvel Life Sciences Ltd.Application withdrawn—
ExuberaPfizer LimitedWithdrawn24/01/2006Diabetes Mellitus
Insulin Human Rapid MarvelMarvel LifeSciences Ltd.Application withdrawnDiabetes Mellitus
Insulin Human Long MarvelMarvel LifeSciences Ltd.Application withdrawnDiabetes Mellitus

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