EMEA-002146-PIP02-18 - paediatric investigation plan

Palbociclib

Key facts

• Invented name:
  Ibrance
• Active Substance:
  Palbociclib
• Therapeutic area:
  Oncology
• Decision number:
  P/0005/2019
• PIP number:
  EMEA-002146-PIP02-18
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate oral dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of breast malignant neoplasms
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/01/2019

Decision

P/0005/2019: EMA decision of 3 January 2019 on the granting of a product specific waiver for palbociclib (IBRANCE) (EMEA-002146-PIP02-18)

AdoptedReference Number: EMA/873059/2018