EMEA-001303-PIP01-12-M04 - paediatric investigation plan

bumetanide

Key facts

• Active substance:
  bumetanide
• Therapeutic area:
  Neurology
• Decision number:
  P/0340/2021
• PIP number:
  EMEA-001303-PIP01-12-M04
• Pharmaceutical form(s):
  Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of autism spectrum disorder
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/08/2021
• Compliance check done:
  No

Decision

P/0340/2021: EMA decision of 9 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bumetanide (EMEA-001303-PIP01-12-M04)

Adopted Reference Number: EMA/439409/2021