EMEA-002263-PIP01-17 - paediatric investigation plan

Trazodone (hydrochloride)

gabapentin

Key facts

• Active Substance:
  • Trazodone (hydrochloride)
  • gabapentin
• Therapeutic area:
  Pain
• Decision number:
  P/0089/2018
• PIP number:
  EMEA-002263-PIP01-17
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of painful diabetic neuropathy
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/03/2018

Decision

P/0089/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for trazodone (hydrochloride) / gabapentin (EMEA-002263- PIP01-17)

AdoptedReference Number: EMA/87985/2018