Nebenwirkungen · MabThera
MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 26
HOS-087613 · Präparat HOS-083527
Paediatric population An open-label, single arm study was conducted in 25 paediatric patients with severe, active GPA or MPA. The overall study period consisted of a 6-month remission induction phase with a minimum 18-month follow-up, up to 4.5 years overall. During the follow-up phase, MabThera was given at the discretion of the investigator (17 out of 25 patients received additional MabThera treatment). Concomitant treatment with other immunosuppressive therapy was permitted (see section 5.1).
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