EMEA-002342-PIP03-18 - paediatric investigation plan

abemaciclib

Key facts

• Invented name:
  Verzenios
• Active substance:
  abemaciclib
• Therapeutic area:
  Oncology
• Decision number:
  P/0202/2019
• PIP number:
  EMEA-002342-PIP03-18
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of breast cancer
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/06/2019
• Compliance check done:
  Non

Decision

P/0202/2019: EMA decision of 12June 2019 on the granting of a product specific waiver for abemaciclib (Verzenios), (EMEA-002342-PIP03-18)

Adopted Reference Number: EMA/288547/2019