EMEA-001279-PIP01-12 - paediatric investigation plan

Co-crystal of tramadol (hydrochloride)

Celecoxib

Key facts

• Active Substance:
  • Co-crystal of tramadol (hydrochloride)
  • Celecoxib
• Therapeutic area:
  Pain
• Decision number:
  P/0195/2012
• PIP number:
  EMEA-001279-PIP01-12
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of pain
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Laboratorios del Dr. Esteve S.A.

  Spain; [e-mail]; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/08/2012

Decision

P/0195/2012: EMA decision of 24 August 2012 on the granting of a product specific waiver for co-crystal of tramadol (hydrochloride) / celecoxib (EMEA-001279-PIP01-12)

AdoptedReference Number: EMA/547672/2012