EMEA-003174-PIP01-21 - paediatric investigation plan

4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1 (pridopidine hydrochloride)

Key facts

• Active Substance:
  4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1 (pridopidine hydrochloride)
• Therapeutic area:
  Neurology
• Decision number:
  P/0546/2022
• PIP number:
  EMEA-003174-PIP01-21
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of Huntington's disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Prilenia Therapeutics B.V.

  E-mail: [e-mail]

  Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/12/2022

Decision

P/0546/2022: EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pridopidine (hydrochloride) (EMEA-003174-PIP01-21)

AdoptedReference Number: EMA/934635/2022