EMEA-002994-PIP01-21 - paediatric investigation plan

gabapentin

Key facts

• Active Substance:
  gabapentin
• Therapeutic area:
  • Neurology
  • Pain
• Decision number:
  P/0335/2021
• PIP number:
  EMEA-002994-PIP01-21
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of postherpetic neuralgia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2021

Decision

P/0335/2021 : EMA decision of 12 August 2021 on the granting of a product specific waiver for gabapentin (EMEA-002994-PIP01-21)

AdoptedReference Number: EMA/382518/2021