EMEA-000308-PIP01-08-M04 - paediatric investigation plan

rituximab
PIPHuman

Key facts

Invented name
  • MabThera
  • 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 6169 79411
E-mail: global.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000308-PIP01-08-M04
Compliance opinion date
Compliance outcome
Positive

Decision

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