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Kuvan



BioMarin International LimitedEU/1/08/481/1-3

Main Information

Trade NameKuvan
Active SubstancesSapropterin dihydrochloride
Dosage FormSoluble tablet
Licence HolderBioMarin International Limited
Licence NumberEU/1/08/481/1-3

Group Information

ATC CodeA16AX07 sapropterin

Status

License statusAuthorised
Licence Issued02/12/2008
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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