EMEA-000118-PIP02-10-M03 - paediatric investigation plan

Abatacept

Key facts

• Invented name:
  • Orencia
  • Orencia
• Active Substance:
  Abatacept
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0128/2014
• PIP number:
  EMEA-000118-PIP02-10-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Bristol-Myers Squibb Pharma EEIG

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/03/2018
• Compliance procedure number:
  EMEA-C-000118-PIP02-10-M03
• Compliance opinion date:
  23/03/2018
• Compliance outcome:
  Positive

Decision

P/0099/2018: EMA decision of 15 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for abatacept (Orencia), (EMEA-000118-PIP02-10-M03)

AdoptedReference Number: EMA/141028/2018