EMEA-000880-PIP02-11-M04 - paediatric investigation plan

sonidegib

Key facts

• Active substance:
  sonidegib
• Therapeutic area:
  Oncology
• Decision number:
  P/0111/2020
• PIP number:
  EMEA-000880-PIP02-11-M04
• Pharmaceutical form(s):
  • Capsule, hard
  • Film-coated tablet
  • Powder and solvent for oral suspension
• Condition(s) / indication(s):
  Treatment of medulloblastoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/03/2020
• Compliance check done:
  No

Decision

P/0111/2020: EMA decision 20 March 2020 on the acceptance of a modification of an agreed paediatric investigation plan for sonidegib (Odomzo), (EMEA-000880-PIP02-11-M04)

Adopted Reference Number: EMA/100871/2020