EMEA-000117-PIP02-10-M07 - paediatric investigation plan

Ipilimumab

Key facts

• Invented name:
  • Yervoy
  • Yervoy
• Active Substance:
  Ipilimumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0003/2017
• PIP number:
  EMEA-000117-PIP02-10-M07
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Bristol-Myers Squibb Pharma EEIG

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/01/2017
• Compliance procedure number:
  EMEA-000117-PIP02-10-M07
• Compliance opinion date:
  24/02/2017
• Compliance outcome:
  Positive

Decision

P/0003/2017: EMA decision of 12 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M07)

AdoptedReference Number: EMA/7963/2017