EMEA-000308-PIP01-08-M04

Key facts

Invented name
MabThera
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 infusion
  • Solution for injection
Condition(s) / indication(s)
  • Treatment of autoimmune arthritis
  • Treatment of diffuse large B-cell lymphoma
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries
Roche Registration GmbH

Tel. +41 6168 79411
E-mail: global.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

How useful was this page?

Add your rating