EMEA-003628-PIP01-24 - paediatric investigation plan

anitocabtagene autoleucel

Key facts

• Active substance:
  anitocabtagene autoleucel
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0300/2024
• PIP number:
  EMEA-003628-PIP01-24
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/08/2024
• Compliance check done:
  No

Decision

P/0300/2024: EMA decision of 14 August 2024 on the granting of a product specific waiver for anitocabtagene autoleucel (EMEA-003628-PIP01-24)

Adopted Reference Number: EMA/364617/2024