EMEA-002532-PIP01-18-M02 - paediatric investigation plan

Phenobarbital

Key facts

• Active Substance:
  Phenobarbital
• Therapeutic area:
  Neurology
• Decision number:
  P/0301/2021
• PIP number:
  EMEA-002532-PIP01-18-M02
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of epilepsy
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  Proveca Pharma Limited

  [e-mail]

  [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2022

Decision

P/0017/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for phenobarbital (EMEA- 002532-PIP01-18-M02)

AdoptedReference Number: EMA/8189/2022