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KUVAN 100 MG SOLUBLE TABLETS

100 Milligram Tablets

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

Main Information

Trade NameKUVAN 100 MG SOLUBLE TABLETS
Active SubstancesSAPROPTERIN DIHYDROCHLORIDE
Strength100 Milligram
Dosage FormTablets
Licence HolderBioMarin International Limited
Licence NumberEU/1/08/481/1-3

Group Information

ATC CodeA16AX07 Various alimentary tract and metabolism products

Status

Authorised/WithdrawnAuthorised
Licence Issued02/12/2008
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)

Documents

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