EMEA-000564-PIP01-09 - paediatric investigation plan

paracetamol

Ibuprofen

Key facts

• Active Substance:
  • paracetamol
  • Ibuprofen
• Therapeutic area:
  Pain
• Decision number:
  P/259/2009
• PIP number:
  EMEA-000564-PIP01-09
• Pharmaceutical form(s):
  • Film-coated tablet
  • Suspension
• Condition(s) / indication(s):
  Acute 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:
  23/12/2009

Decision

P/259/2009: EMA decision of 23 December 2009 on the granting of a product specific waiver for paracetamol / ibuprofen (EMEA-000564-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the E...

AdoptedReference Number: EMA/749493/2009