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
• Contact for public enquiries:

  Prilenia Therapeutics B.V.

  E-mail: [e-mail]

  Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2022

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)

AdoptedReference Number: EMA/824829/2022