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PRODUCT DETAIL

Fabrazyme 35 mg prášok na koncentrát na infúzny roztok

Code 32648
MA number EU/1/01/188/003
Product Form: plc ifc 10x35 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Sanofi B.V., Netherland
Therapeutic Class: 87 - VARIA I
ATC:
A ALIMENTARY TRACT AND METABOLISM
A16 OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16A OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16AB Enzymes
A16AB04 Agalsidase beta
Shelf life: 36
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application
MA issued: 03.08.2001
SmPC + PL: European Medicines Agency's database
Dokument: Fabrazyme DHPC September_SK_approved.pdf  
Dokument: Fabrazyme DHPC September_SK_approved.pdf  
Dokument: DHCP Fabrazyme -19 2 2010_GIB.pdf  
Dokument: DHCP Fabrazyme 26 4 2010_SK.pdf  
Dokument: SK DHPC Fabrazyme 12 7 2010.pdf  
Safety feature Yes
Data update: 23.07.2021
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