Tramadol hydrochloride, Paracetamol - paediatric investigation plan

Tramadol hydrochloride

paracetamol

Key facts

• Active Substance:
  • Tramadol hydrochloride
  • paracetamol
• Therapeutic area:
  Pain
• Decision number:
  P/260/2009
• PIP number:
  Tramadol hydrochloride, Paracetamol
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Pain
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Labopharm Europe Limited

  E-mail: [e-mail]; Country: Ireland; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/12/2009

Decision

P/260/2009: EMA decision of 23 December 2009 on the granting of a product specific waiver for tramadol hydrochloride / paracetamol (EMEA-000680-PIP01-09) in accordance with Regulation (EC) No 1901/...

AdoptedReference Number: EMA/749363/2009