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PRODUCT DETAIL

Soliris 300 mg koncentrát na infúzny roztok

Code 43567
MA number EU/1/07/393/001
Product Form: con inf 1x30 ml/300 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AJ Complement inhibitors
L04AJ01 Eculizumab
Shelf life: 30
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 20.06.2007
SmPC + PL: European Medicines Agency's database
Dokument: SOLIRIS_Karta pacienta.pdf  
Dokument: SOLIRIS_Prirucka pre lekarov.pdf  
Dokument: SOLIRIS_Prirucka pre pacienta.pdf  
Safety feature Yes
Data update: 21.11.2023
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