EMEA-000486-PIP01-08-M04 - paediatric investigation plan

Tapentadol (hydrochloride)

Key facts

• Invented name:
  Palexia and associated names
• Active Substance:
  Tapentadol (hydrochloride)
• Therapeutic area:
  Pain
• Decision number:
  P/0044/2016
• PIP number:
  EMEA-000486-PIP01-08-M04
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Prolonged-release granules
• Condition(s) / indication(s):
  Treatment of chronic pain
• Route(s) of administration:
  Oral 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:
  27/02/2016

Decision

P/0044/2016: EMA decision of 26 February 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names and T...

Reference Number: EMA/133035/2016