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PRODUCT DETAIL

Cerezyme 400 jednotiek prášok na infúzny koncentrát

Code 40762
MA number EU/1/97/053/004
Product Form: plc ifc 5x400 U (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
A16AB02 Imiglucerase
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: 17.11.1997
SmPC + PL: European Medicines Agency's database
Dokument: DHPC_Cerezyme_ 30 11 2009_rev_ approved.pdf  
Dokument: DHCP Cerezyme 19 2 2010_GIB.pdf  
Dokument: DHCP Cerezyme 26 4 2010_SK.pdf  
Dokument: DHPC Cerezyme -23 09 2010 SVK.pdf  
Dokument: SK DHPC Cerezyme 12 7 2010.pdf  
Safety feature Yes
Data update: 10.01.2019
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