EMEA-002971-PIP01-21 - paediatric investigation plan

nirogacestat hydrobromide

Key facts

• Active substance:
  nirogacestat hydrobromide
• Therapeutic area:
  Oncology
• Decision number:
  P/0032/2022
• PIP number:
  EMEA-002971-PIP01-21
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of soft tissue sarcoma
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2022
• Compliance check done:
  No

Decision

P/0032/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for nirogacestat hydrobromide (EMEA-002971-PIP01-21)

Adopted Reference Number: EMA/10020/2022