EMEA-000713-PIP02-10-M05 - paediatric investigation plan

pixantrone dimaleate

Key facts

• Invented name:
  • Pixuvri
  • Pixuvri
• Active substance:
  pixantrone dimaleate
• Therapeutic area:
  Oncology
• Decision number:
  P/0227/2018
• PIP number:
  EMEA-000713-PIP02-10-M05
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of non-Hodgkin lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/07/2018
• Compliance check done:
  Nein

Decision

P/0227/2018: EMA decision of 20 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for pixantrone (dimaleate) (Pixuvri), (EMEA-000713-PIP02-10-M05)

Adopted Reference Number: EMA/469707/2018