EMEA-002623-PIP01-19 - paediatric investigation plan

ondansetron (hydrochloride)

Key facts

• Active substance:
  ondansetron (hydrochloride)
• Therapeutic area:
  • Neurology
  • Other
• Decision number:
  P/0248/2020
• PIP number:
  EMEA-002623-PIP01-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of alcohol use disorder
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/07/2020
• Compliance check done:
  No

Decision

P/0248/2020: EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for ondansetron (hydrochloride) (EMEA-002623-PIP01-19)

Adopted Reference Number: EMA/356098/2020