EMEA-000494-PIP01-08-M09 - paediatric investigation plan

tapentadol hydrochloride

Key facts

• Invented name:
  • Palexia and associated names; Yantil and associated names
  • Tapentadol and associated names
• Active substance:
  tapentadol hydrochloride
• Therapeutic area:
  Pain
• Decision number:
  P/0092/2016
• PIP number:
  EMEA-000494-PIP01-08-M09
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
  • Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of acute pain
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/03/2016
• Compliance check done:
  No

Decision

P/0092/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tapenta...

Reference Number: EMA/188340/2016