EMEA-003174-PIP02-22 - paediatric investigation plan

pridopidine hydrochloride

Key facts

• Active substance:
  pridopidine hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/0418/2022
• PIP number:
  EMEA-003174-PIP02-22
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0418/2022: EMA decision of 28 October 2022 on the granting of a product specific waiver for pridopidine (hydrochloride) (EMEA-003174-PIP02-22)

Adopted Reference Number: EMA/824829/2022