EMEA-000118-PIP01-07-M01 - paediatric investigation plan

abatacept

Key facts

• Invented name:
  • Orencia
  • Orencia
• Active substance:
  abatacept
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/100/2009
• PIP number:
  EMEA-000118-PIP01-07-M01
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Juvenile Arthritis
  • Rheumatoid arthritis
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/05/2009
• Compliance check done:
  Taip
• Compliance procedure number:
  EMEA-C-000118-PIP01-07-M01
• Compliance opinion date:
  29/05/2009
• Compliance outcome:
  Positive

Decision

P/100/2009: European Medicines Agency decision of 19 May 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for abatacept (ORENCIA) (EMEA-000118-PIP01-07-M01) in accordance with Regulatio...

Adopted Reference Number: EMEA/290591/2009