EMEA-002147-PIP02-17-M01 - paediatric investigation plan

sodium thiosulfate

Key facts

• Active substance:
  sodium thiosulfate
• Therapeutic area:
  Oncology
• Decision number:
  P/0368/2019
• PIP number:
  EMEA-002147-PIP02-17-M01
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Prevention of platinum-induced ototoxic hearing loss
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/11/2019
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002147-PIP02-17-M01
• Compliance opinion date:
  11/12/2019
• Compliance outcome:
  Positive

Decision

P/0368/2019: EMA decision of 8 November 2019 on the acceptance of a modification of an agreed paediatric investigation plan for sodium thiosulfate (STS), (EMEA-002147-PIP02-17-M01)

Adopted Reference Number: EMA/591617/2019