EMEA-000056-PIP01-07-M02 - paediatric investigation plan

bevacizumab

Key facts

• Invented name:
  • Avastin
  • Avastin
• Active Substance:
  bevacizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0004/2014
• PIP number:
  EMEA-000056-PIP01-07-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of non-rhabdomyosarcoma soft tissue sarcoma
  • Treatment of rhabdomyosarcoma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Roche Registration Ltd

  United Kingdom; E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/01/2014
• Compliance procedure number:
  EMEA-C-000056-PIP01-07-M02
• Compliance opinion date:
  26/02/2016
• Compliance outcome:
  Positive

Decision

P/0004/2014: 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-PIP01-07-M02)

AdoptedReference Number: EMA/738884/2013