Page contents Key factsDecisionRelated medicine informationTopicsKey facts Invented name MabTheraMabThera Active Substance rituximab Therapeutic area Oncology Decision number P/0064/2019 PIP number EMEA-000308-PIP01-08-M04 Pharmaceutical form(s) Concentrate for solution for infusionSolution for injection Condition(s) / indication(s) Treatment of autoimmune arthritisTreatment of diffuse large B-cell lymphoma Route(s) of administration Intravenous useSubcutaneous use Contact for public enquiries Roche Registration GmbHTel. +41 6169 79411 E-mail: global.paediatrics@roche.com Decision type PM: decision on the application for modification of an agreed PIP Decision date 22/03/2019 Compliance procedure number EMEA-C-000308-PIP01-08-M04 Compliance opinion date 29/05/2019 Compliance outcome Positive DecisionP/0064/2019: EMA decision of 22 March 2019 on the acceptance of a modification of an agreed paediatric investigation plan for rituximab (MabThera)AdoptedReference Number: EMA/112081/2019 English (EN) (188.34 KB - PDF)First published: 21/06/2019ViewRelated medicine informationMabTheraTopicsPaediatricsShare this page