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PRODUCT DETAIL

RoActemra 162 mg injekčný roztok v naplnenej injekčnej striekačke

Code 9954A
MA number EU/1/08/492/007
Product Form: sol inj 4x0,9 ml/162 mg (striek.inj.napl.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Roche Registration GmbH, Germany
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AC Interleukin inhibitors
L04AC07 Tocilizumab
Shelf life: 24
Container: glass vial
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application
MA issued: 23.04.2014
SmPC + PL: European Medicines Agency's database
Dokument: tocilizumab_prirucka pre pacienta.pdf  
Dokument: tocilizumab_prirucka k podavaniu lieku.pdf  
Dokument: tocilizumab_prirucka pre zdravotnickych pracovnikov.pdf  
Dokument: tocilizumab_karta pacienta.pdf  
Safety feature Yes
Data update: 01.02.2023
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