Tramadol / paracetamol - paediatric investigation plan

tramadol

paracetamol

Key facts

• Active substance:
  • tramadol
  • paracetamol
• Therapeutic area:
  Pain
• Decision number:
  W/185/2009
• PIP number:
  Tramadol / paracetamol
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Moderate to severe 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:
  07/09/2009
• Compliance check done:
  No

Decision

P/185/2009: european medicines agency decision of 7 September 2009 on the granting of a product specific waiver for tramadol / paracetamol (EMEA-000598-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the E...

Adopted Reference Number: EMEA/548803/2009