EMEA-000308-PIP02-11-M01 - paediatric investigation plan

rituximab

Key facts

• Invented name:
  • MabThera
  • MabThera
• Active Substance:
  rituximab
• Therapeutic area:
  Oncology
• Decision number:
  P/0060/2016
• PIP number:
  EMEA-000308-PIP02-11-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of microscopic polyangiitis
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Roche Registration Limited

  Switzerland; Tel. [phone]; Fax [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/03/2016
• Compliance procedure number:
  EMEA-C-000308-PIP02-11-M01
• Compliance opinion date:
  01/02/2019
• Compliance outcome:
  Positive

Decision

P/0060/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for rituximab (MabThera) (EMEA-000308-PIP02-11-M01)

Reference Number: EMA/138312/2016