EMEA-003161-PIP02-24 - paediatric investigation plan

golcadomide hydrochloride

Key facts

• Active substance:
  golcadomide hydrochloride
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0400/2024
• PIP number:
  EMEA-003161-PIP02-24
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of mature B cell neoplasms
• 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:
  03/01/2025
• Compliance check done:
  No

Decision

P/0400/2024 : EMA decision of 3 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for golcadomide (EMEA-003161-PIP02-24)

Adopted Reference Number: EMA/566316/2024