EMEA-000056-PIP03-10-M02 - paediatric investigation plan

bevacizumab

Key facts

• Invented name:
  • Avastin
  • Avastin
• Active Substance:
  bevacizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0005/2014
• PIP number:
  EMEA-000056-PIP03-10-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of high-grade glioma
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/01/2014
• Compliance procedure number:
  EMEA-C-000056-PIP03-10-M02
• Compliance opinion date:
  13/11/2015
• Compliance outcome:
  Positive

Decision

P/0005/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for bevacizumab (Avastin), (EMEA-000056-PIP03-10-M02)

AdoptedReference Number: EMA/738885/2013