EMEA-000883-PIP01-10-M05 - paediatric investigation plan

treosulfan

Key facts

• Invented name:
  Trecondi
• Active substance:
  treosulfan
• Therapeutic area:
  • Immunology-Rheumatology-Transplantation
  • Oncology
• Decision number:
  P/0346/2020
• PIP number:
  EMEA-000883-PIP01-10-M05
• Pharmaceutical form(s):
  Powder for solution
• Condition(s) / indication(s):
  Conditioning treatment prior to haematopoietic-progenitor-cell transplantation
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000883-PIP01-10-M05
• Compliance opinion date:
  25/03/2022
• Compliance outcome:
  Positive

Decision

P/0346/2020: EMA decision of 9 September 2020 on the acceptance of a modification of an agreed paediatric investigation plan for treosulfan (Trecondi), (EMEA-000883-PIP01-10-M05)

Adopted Reference Number: EMA/415145/2020