EMEA-003447-PIP01-23 - paediatric investigation plan

5-{4-[(7-ethyl-6-oxo-5,6-dihydro-1,5-naphthyridin-3-yl)methyl]-1-piperazinyl}-N-methyl-2-pyridinecarboxamide

Key facts

• Active substance:
  5-{4-[(7-ethyl-6-oxo-5,6-dihydro-1,5-naphthyridin-3-yl)methyl]-1-piperazinyl}-N-methyl-2-pyridinecarboxamide
• Therapeutic area:
  Oncology
• Decision number:
  P/0356/2023
• PIP number:
  EMEA-003447-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  • Treatment of breast cancer
  • 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:
  No

Decision

P/0356/2023: EMA decision of 8 September 2023 on the granting of a product specific waiver for 5-{4-[(7-ethyl-6-oxo-5,6-dihydro-1,5-naphthyridin-3- yl)methyl]-1-piperazinyl}-N-methyl-2-pyridinecarboxamide (EMEA-003447-PIP01-23)

Adopted Reference Number: EMA/380490/2023