EMEA-000018-PIP01-07-M14 - 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/0355/2017
• PIP number:
  EMEA-000018-PIP01-07-M14
• 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
• Contact for public enquiries:

  Grünenthal GmbH

  Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2017

Decision

P/0355/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tape...

AdoptedReference Number: EMA/704024/2017