EMEA-002152-PIP01-17-M04 - paediatric investigation plan

daratumumab

Key facts

• Invented name:
  Darzalex
• Active substance:
  daratumumab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0339/2024
• PIP number:
  EMEA-002152-PIP01-17-M04
• Pharmaceutical form(s):
  • Solution for injection
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of lymphoid malignancies (except mature B-cell neoplasms)
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  Yes
• Compliance procedure number:
  EMA/PE/0000233203
• Compliance opinion date:
  13/12/2024
• Compliance outcome:
  Positive

Decision

P/0339/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for daratumumab (Darzalex), (EMEA-002152-PIP01-17-M04)

Adopted Reference Number: EMA/414389/2024