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ACTIVE SUBSTANCE / INN

HUMAN NORMAL IMMUNOGLOBULIN

Brand name(s): Kiovig, Flebogamma DIF (previously Flebogammadif), HyQvia, Deqsiga
EMA LISTED
AUTHORISED
Mucocutaneous Lymph Node Syndrome;Guillain-Barre Syndrome;Bo…
Immunologic Deficiency Syndromes;Polyradiculoneuropathy;Poly…
ACTIVE SUBSTANCE
Human Normal Immunoglobulin
REGULATORS
EMA
SPONSORS / MAH
Instituto Grifols S.A., Baxalta Innovations GmbH, Takeda Manufacturing Austria AG
TOTAL APPLICATIONS
4
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
HyQviaBaxalta Innovations GmbHAuthorised16/05/2013Immunologic Deficiency Syndromes;Polyradiculoneuropathy;Polyradiculoneuropathy, …
DeqsigaTakeda Manufacturing Austria AGAuthorised02/05/2025Immunologic Deficiency Syndromes;Purpura, Thrombocytopenic, Idiopathic;Guillain-…
Flebogamma DIF (previously Flebogammadif)Instituto Grifols S.A.Authorised23/07/2007Mucocutaneous Lymph Node Syndrome;Guillain-Barre Syndrome;Bone Marrow Transplant…
KiovigTakeda Manufacturing Austria AGAuthorised19/01/2006Purpura, Thrombocytopenic, Idiopathic;Bone Marrow Transplantation;Immunologic De…

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