EMEA-003174-PIP01-21-M01 - paediatric investigation plan

Pridopidine hydrochloride

Key facts

• Active Substance:
  Pridopidine hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/0496/202
• PIP number:
  EMEA-003174-PIP01-21-M01
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of Huntington's disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023

Decision

P/0496/2023: EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for pridopidine (hydrochloride) (EMEA-003174-PIP01-21-M01)

AdoptedReference Number: EMA/531238/2023