EMA/PE/0000182075 - paediatric investigation plan

venetoclax

Key facts

• Invented name:
  Venclyxto
• Active substance:
  venetoclax
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000182075
• PIP number:
  EMA/PE/0000182075
• Pharmaceutical form(s):
  • Film-coated tablet
  • Tablet for oral suspension
  • Powder for oral suspension
• Condition(s) / indication(s):
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Treatment of solid malignant tumours
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000182075 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for Venetoclax (Venclyxto)

Adopted Reference Number: EMADOC-1700519818-1796802