EMEA-000308-PIP01-08-M03

Key facts

Invented name
MabThera
Active substance
rituximab
Therapeutic area
Oncology
Decision number
P/0113/2017
PIP number
EMEA-000308-PIP01-08-M03
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 Limited

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

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

Decision

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