ACTIVE SUBSTANCE / INN

SAPROPTERIN

Brand name(s): Sapropterin Dipharma, Kuvan
EMA LISTED
AUTHORISED
Phenylketonurias
ACTIVE SUBSTANCE
Sapropterin
REGULATORS
EMA
SPONSORS / MAH
BioMarin International Limited, Dipharma Arzneimittel GmbH
TOTAL APPLICATIONS
2
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Sapropterin DipharmaDipharma Arzneimittel GmbHAuthorised16/02/2022Phenylketonurias
KuvanBioMarin International LimitedAuthorised02/12/2008Phenylketonurias

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