EMEA-001808-PIP03-17 - paediatric investigation plan

Sarizotan (hydrochloride)

Key facts

• Active Substance:
  Sarizotan (hydrochloride)
• Therapeutic area:
  Neurology
• Decision number:
  P/0287/2018
• PIP number:
  EMEA-001808-PIP03-17
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of Rett syndrome
• 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:
  12/09/2018

Decision

P/0287/2018: EMA decision of 12 September 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sarizotan (hydrochloride) (EMEA-001808-PIP03-17)

AdoptedReference Number: EMA/517241/2018