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ACTIVE SUBSTANCE / INN

INSULIN ASPART

Brand name(s): RYZODEG 70/30, FIASP, Truvelog Mix 30, Dazparda, Kirsty (previously Kixelle), Insulin Aspart Injection, FIASP FLEXTOUCH, NovoRapid, Insulin aspart Sanofi, FIASP PENFILL, NovoMix, Fiasp
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
APPLICATION WITHDRAWN
BLA203313
BLA208751
ACTIVE SUBSTANCE
Insulin Aspart
REGULATORS
FDA · EMA
SPONSORS / MAH
Masuu Pharma Europe Limited, Novo Nordisk A/S, Gan & Lee Pharmaceuticals Europe GmbH
TOTAL APPLICATIONS
12
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FIASP PENFILLBLA208751NOVOPrescription
FIASPBLA208751NOVOPrescription
FIASP FLEXTOUCHBLA208751NOVOPrescription
RYZODEG 70/30BLA203313NOVODiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Kirsty (previously Kixelle)Biosimilar Collaborations Ireland LimitedAuthorised05/02/2021Diabetes Mellitus
DazpardaGan & Lee Pharmaceuticals Europe GmbHOpinionDiabetes Mellitus
Insulin aspart SanofiSanofi Winthrop IndustrieAuthorised25/06/2020Diabetes Mellitus
Insulin Aspart InjectionMasuu Pharma Europe LimitedApplication withdrawnDiabetes Mellitus
NovoRapidNovo Nordisk A/SAuthorised07/09/1999Diabetes Mellitus
NovoMixNovo Nordisk A/SAuthorised01/08/2000Diabetes Mellitus
Truvelog Mix 30Sanofi Winthrop IndustrieAuthorised25/04/2022Diabetes Mellitus
FiaspNovo Nordisk A/SAuthorised09/01/2017Diabetes Mellitus

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