EMEA-001599-PIP01-13 - paediatric investigation plan

Ibuprofen (sodium dihydrate)

Key facts

• Active Substance:
  Ibuprofen (sodium dihydrate)
• Therapeutic area:
  Other
• Decision number:
  P/0255/2014
• PIP number:
  EMEA-001599-PIP01-13
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  • Treatment of febrile disorders
  • Treatment of pain
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/09/2014

Decision

P/0255/2014: EMA decision of 30 September 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for ibuprofen (sodium dihydrate), (EMEA-001599-PIP01-13)

AdoptedReference Number: EMA/519929/2014