EMEA-001310-PIP01-12-M03 - paediatric investigation plan

gabapentin

Key facts

• Active substance:
  gabapentin
• Therapeutic area:
  Pain
• Decision number:
  P/0198/2018
• PIP number:
  EMEA-001310-PIP01-12-M03
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of chronic pain
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/07/2018
• Compliance check done:
  Не

Decision

P/0198/2018: EMA decision of 19 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for gabapentin (EMEA-001310-PIP01-12-M03)

Adopted Reference Number: EMA/421374/2018