EMEA-002765-PIP02-21-M01 - paediatric investigation plan

ribociclib

Key facts

• Invented name:
  Kisqali
• Active substance:
  ribociclib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0266/2024
• PIP number:
  EMEA-002765-PIP02-21-M01
• Pharmaceutical form(s):
  • Age appropriate oral liquid dosage formulation
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of neuroblastoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/07/2024
• Compliance check done:
  Ne

Decision

P/0266/2024: EMA decision of 17 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ribociclib (Kisqali), (EMEA-002765-PIP02-21-M01)

Adopted Reference Number: EMA/328854/2024