EMEA-001887-PIP01-15 - paediatric investigation plan

Ibuprofen

tramadol

Key facts

• Active substance:
  • Ibuprofen
  • tramadol
• Therapeutic area:
  Pain
• Decision number:
  P/0153/2016
• PIP number:
  EMEA-001887-PIP01-15
• Pharmaceutical form(s):
  • Solution for infusion
  • Granules for oral solution
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of pain
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2016
• Compliance check done:
  No

Decision

P/0153/2016: EMA decision of 14 June 2016 on the granting of a product specific waiver for ibuprofen / tramadol (EMEA-001887-PIP01-15)

Adopted Reference Number: EMA/334199/2016