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ACTIVE SUBSTANCE / INN

IDURSULFASE

Brand name(s): ELAPRASE, Elaprase
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
BLA125151
Mucopolysaccharidosis II
ACTIVE SUBSTANCE
Idursulfase
REGULATORS
FDA · EMA
SPONSORS / MAH
SHIRE, Takeda Pharmaceuticals International AG Ireland Branch
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ELAPRASEBLA125151SHIREPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ElapraseTakeda Pharmaceuticals International AG Ireland BranchAuthorised08/01/2007Mucopolysaccharidosis II

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