Fentanyl citrate - paediatric investigation plan

Fentanyl citrate

Key facts

• Active substance:
  Fentanyl citrate
• Therapeutic area:
  Pain
• Decision number:
  P/258/2009
• PIP number:
  Fentanyl citrate
• Pharmaceutical form(s):
  • Nasal spray
  • Solution
• Condition(s) / indication(s):
  Acute pain
• Route(s) of administration:
  Nasal use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  23/12/2009
• Compliance check done:
  No

Decision

P/258/2009: EMA decision of 23 December 2009 on the refusal of a Paediatric Investigation Plan and on the refusal of a deferral and on the refusal of a waiver for fentanyl citrate (EMEA-000481-PIP0...

Adopted Reference Number: EMA/749288/2009