Etanercept - paediatric investigation plan

etanercept

Key facts

• Invented name:
  • Enbrel
  • Enbrel
• Active Substance:
  etanercept
• Therapeutic area:
  Dermatology
• Decision number:
  P/241/2011
• PIP number:
  Etanercept
• Pharmaceutical form(s):
  • Powder and solvent for solution for injection
  • Powder for solution for injection
  • Powder and solvent for solution for injection for paediatric use
  • Solution for injection
• Condition(s) / indication(s):
  • Juvenile idiopathic arthritis
  • Plaque psoriasis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/09/2011
• Compliance procedure number:
  EMEA-C-000299-PIP01-08-M03
• Compliance opinion date:
  13/12/2011
• Compliance outcome:
  Positive

Decision

P/241/2011: EMA decision of 29 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for etanercept (Enbrel) (EMEA-000299-PIP01-08-M03)

AdoptedReference Number: EMA/764025/2011