EMEA-003358-PIP01-22 - paediatric investigation plan

Key facts

• Therapeutic area:
  Oncology
• Decision number:
  P/0138/2023
• PIP number:
  EMEA-003358-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of breast malignant neoplasms
• 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:
  14/04/2023
• Compliance check done:
  No

Decision

P/0138/2023 : EMA decision of 14 April 2023 on granting of product specific waiver for (3S)-3-(5-{4-[(1-{4-[(1R,2S)-6-hydroxy-2-phenyl-1,2,3,4-tetrahydronaphthalen-1-yl]phenyl}piperidin-4-yl)methyl]piperazin-1-yl}-1-oxo-1,3-dihydro-2H-isoindol-2yl)...

Reference Number: EMA/108922/2023