EMEA-000117-PIP01-07-M07 - paediatric investigation plan

Ipilimumab

Key facts

• Invented name:
  • Yervoy
  • Yervoy
• Active substance:
  Ipilimumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0085/2015
• PIP number:
  EMEA-000117-PIP01-07-M07
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except melanoma, nervous system, haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/05/2015
• Compliance check done:
  Tak
• Compliance procedure number:
  EMEA-C-000117-PIP01-07-M07
• Compliance opinion date:
  11/12/2015
• Compliance outcome:
  Positive

Decision

P/0085/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M07)

Reference Number: EMA/215073/2015