EMEA-002205-PIP01-17-M04 - paediatric investigation plan

Isatuximab

Key facts

• Invented name:
  Sarclisa
• Active substance:
  Isatuximab
• Therapeutic area:
  Oncology
• Decision number:
  P/0144/2023
• PIP number:
  EMEA-002205-PIP01-17-M04
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/04/2023
• Compliance check done:
  Jā
• Compliance procedure number:
  EMEA-C-002205-PIP01-17-M04
• Compliance opinion date:
  15/12/2023
• Compliance outcome:
  Positive

Decision

P/0144/2023 : EMA decision of 21 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for isatuximab (Sarclisa), (EMEA-002205-PIP01-17-M04)

Reference Number: EMA/163887/2023