EMEA-003588-PIP01-24 - paediatric investigation plan

7-ethyl-10-hydroxy-camptothecin

Key facts

• Active substance:
  7-ethyl-10-hydroxy-camptothecin
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0394/2024
• PIP number:
  EMEA-003588-PIP01-24
• Pharmaceutical form(s):
  Implant
• Condition(s) / indication(s):
  Treatment of soft tissue sarcoma
• Route(s) of administration:
  Implant use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

P/0394/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan for 7-ethyl-10-hydroxy-camptothecin (SN-38) (EMEA-003588-PIP01-24)

Adopted Reference Number: EMA/554382/2024