EMEA-002342-PIP05-23 - paediatric investigation plan

abemaciclib

Key facts

• Invented name:
  Verzenios
• Active substance:
  abemaciclib
• Therapeutic area:
  Oncology
• Decision number:
  P/0367/2023
• PIP number:
  EMEA-002342-PIP05-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of prostate cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2023
• Compliance check done:
  Ne

Decision

EMA/384130/2023 : EMA decision of 8 September 2023 on the granting of a product specific waiver for abemaciclib (Verzenios), (EMEA-002342-PIP05-23)

Reference Number: EMA/384130/2023