EMEA-001302-PIP01-12 - paediatric investigation plan

Dexketoprofen (trometamol)

tramadol hydrochloride

Key facts

• Active substance:
  • Dexketoprofen (trometamol)
  • tramadol hydrochloride
• Therapeutic area:
  Pain
• Decision number:
  P/0244/2012
• PIP number:
  EMEA-001302-PIP01-12
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of 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:
  22/10/2012
• Compliance check done:
  Nee

Decision

P/0244/2012: EMA decision of 22 October 2012 on the granting of a product specific waiver for dexketoprofen (trometamol) / tramadol (hydrochloride) (EMEA-001302-PIP01-12)

Adopted Reference Number: EMA/660593/2012