EMEA-001617-PIP01-14 - paediatric investigation plan

ethosuximide

Key facts

• Active Substance:
  ethosuximide
• Therapeutic area:
  Neurology
• Decision number:
  P/0315/2015
• PIP number:
  EMEA-001617-PIP01-14
• Pharmaceutical form(s):
  Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of childhood absence epilepsy
• 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:
  21/12/2015

Decision

P/0315/2015: EMA decision of 21 December 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for ethosuximide (EMEA-001617-PIP01-14)

AdoptedReference Number: EMA/781916/2015