EMEA-002146-PIP01-17-M04 - paediatric investigation plan

Palbociclib

Key facts

• Invented name:
  Ibrance
• Active Substance:
  Palbociclib
• Therapeutic area:
  Oncology
• Decision number:
  P/0117/2022
• PIP number:
  EMEA-002146-PIP01-17-M04
• Pharmaceutical form(s):
  • Age-appropriate oral dosage form
  • Capsule, hard
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of Ewing sarcoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022

Decision

P/0117/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for palbociclib (Ibrance), (EMEA-002146-PIP01-17-M04)

AdoptedReference Number: EMA/149197/2022