P/12/2009 - paediatric investigation plan

Ibuprofen

paracetamol

Key facts

• Active Substance:
  • Ibuprofen
  • paracetamol
• Therapeutic area:
  Pain
• Decision number:
  P/12/2009
• PIP number:
  P/12/2009
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Fever
  • Pain
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  PAREXEL Consulting

  E-mail:[e-mail]; Country: UK; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/01/2009

Decision

P/12/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product specific waiver for ibuprofen, paracetamol, (EMEA-000313-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Euro...

AdoptedReference Number: EMEA/29899/2009