EMEA-003489-PIP01-23 - paediatric investigation plan

sonrotoclax

Key facts

• Active substance:
  sonrotoclax
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMEA-003489-PIP01-23
• PIP number:
  EMEA-003489-PIP01-23
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate dosage form
• Condition(s) / indication(s):
  Treatment of malignant neoplasms of haematopoietic and lymphoid tissue
• 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:
  16/04/2025
• Compliance check done:
  No

Decision

EMEA-003489-PIP01-23 : EMA decision of 16 April 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral for sonrotoclax

Adopted Reference Number: EMADOC-1700519818-2023232