EMEA-000018-PIP01-07-M12 - paediatric investigation plan

Tapentadol (hydrochloride)

Key facts

• Invented name:
  Yantil and associated names; Palexia and associated names; Tapentadol and associated names
• Active Substance:
  Tapentadol (hydrochloride)
• Therapeutic area:
  Pain
• Decision number:
  P/0315/2016
• PIP number:
  EMEA-000018-PIP01-07-M12
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
• Condition(s) / indication(s):
  Treatment of acute pain
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Contact for public enquiries:

  Grünenthal GmbH

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/12/2016

Decision

P/0315/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tape...