EMEA-000342-PIP01-08-M07 - paediatric investigation plan

sunitinib

Key facts

• Invented name:
  • Sutent
  • Sutent
• Active substance:
  sunitinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0147/2018
• PIP number:
  EMEA-000342-PIP01-08-M07
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of gastro-intestinal stromal tumours
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/05/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000342-PIP01-08-M07
• Compliance opinion date:
  29/06/2018
• Compliance outcome:
  Positive

Decision

P/0147/2018: EMA decision of 7 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sunitinib (Sutent), (EMEA-000342-PIP01-08-M07)

Adopted Reference Number: EMA/258873/2018