EMEA-002018-PIP02-16-M05 - paediatric investigation plan

Venetoclax

Key facts

• Invented name:
  Venclyxto
• Active Substance:
  Venetoclax
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0148/2022
• PIP number:
  EMEA-002018-PIP02-16-M05
• 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
• Contact for public enquiries:

  AbbVie Ltd

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022

Decision

P/0148/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for venetoclax (Venclyxto), (EMEA-002018-PIP02-16-M05)

AdoptedReference Number: EMA/206375/2022