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

rituximab

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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/03/2019
• Compliance check done:
  Taip
• Compliance procedure number:
  EMEA-C-000308-PIP01-08-M04
• Compliance opinion date:
  29/05/2019
• Compliance outcome:
  Positive

Decision

P/0064/2019: EMA decision of 22 March 2019 on the acceptance of a modification of an agreed paediatric investigation plan for rituximab (MabThera)

Adopted Reference Number: EMA/112081/2019