EMEA-002002-PIP02-17 - paediatric investigation plan

Ibuprofen

paracetamol

Key facts

• Active Substance:
  • Ibuprofen
  • paracetamol
• Therapeutic area:
  Pain
• Decision number:
  P/0135/2018
• PIP number:
  EMEA-002002-PIP02-17
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  • Treatment of febrile disorders
  • 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:
  07/05/2018

Decision

P/0135/2018: EMA decision of 7 May 2018 on the granting of a product-specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP02-17)

AdoptedReference Number: EMA/258445/2018