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PRODUCT DETAIL

MabThera 500 mg infúzny koncentrát

Code 46130
MA number EU/1/98/067/002
Product Form: con inf 1x500 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01X OTHER ANTINEOPLASTIC AGENTS
L01XC Monoclonal antibodies
L01XC02 Rituximab
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: 02.06.1998
SmPC + PL: European Medicines Agency's database
Dokument: MabThera DHCP 04 11 2009 SK.pdf  
Dokument: DHPC MabThera 8 11 2013.pdf  
Dokument: DHPC MabThera TEN and SJS 12 4 2013.pdf  
Dokument: DHPC MabThera Informacia 15 8 2011.pdf  
Safety feature Yes
Data update: 18.10.2019
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