Key facts

Active Substance
Recombinant anti-human CD20 and anti-human CD3 monoclonal antibody (RO7082859; CD20 CD3 TCB)
Therapeutic area
Oncology
Decision number
P/0094/2020
PIP number
EMEA-002648-PIP01-19
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of mature B-cell neoplasms
Route(s) of administration
Intravenous use
Contact for public enquiries

Roche Registration GmbH

Tel. +41 616879411
E-mail: global.paediatrics@roche.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

How useful do you find this page?