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Genzyme Europe B.V.EU/1/01/188/003

Main Information

Trade NameFabrazyme
Active SubstancesProtein c agalsidase beta (recombinant human-a-galactoside a)
Dosage FormPowder for concentrate for solution for infusion
Licence HolderGenzyme Europe B.V.
Licence NumberEU/1/01/188/003

Group Information

ATC CodeA16AB Enzymes
A16AB04 agalsidase beta


License statusAuthorised
Licence Issued
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


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

Educational Materials - HCP

Educational Materials - Patient

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