EMEA-002002-PIP01-16 - paediatric investigation plan

Ibuprofen

paracetamol

Key facts

• Active substance:
  • Ibuprofen
  • paracetamol
• Therapeutic area:
  Pain
• Decision number:
  P/0267/2016
• PIP number:
  EMEA-002002-PIP01-16
• Pharmaceutical form(s):
  • Granules
  • Tablet
• Condition(s) / indication(s):
  Treatment of pain
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/10/2016
• Compliance check done:
  No

Decision

P/0267/2016: EMA decision of 5 October 2016 on the granting of a product specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP01-16)

Adopted Reference Number: EMA/585779/2016