EMEA-001748-PIP03-19 - paediatric investigation plan

arimoclomol citrate

Key facts

• Active substance:
  arimoclomol citrate
• Therapeutic area:
  Neurology
• Decision number:
  P/0012/2021
• PIP number:
  EMEA-001748-PIP03-19
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• 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:
  28/01/2021
• Compliance check done:
  No

Decision

P/0012/2021 : EMA decision of 28 January 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for arimoclomol (citrate) (EMEA-001748-PIP03-19)

Adopted Reference Number: EMA/694570/2020