EMEA-000118-PIP03-15 - paediatric investigation plan

abatacept

Key facts

• Invented name:
  Orencia
• Active substance:
  abatacept
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0005/2017
• PIP number:
  EMEA-000118-PIP03-15
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/01/2017
• Compliance check done:
  No

Decision

P/0005/2017: European Medicines Agency decision of 16 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for abatacept (Orencia), (EMEA-0001...

Adopted Reference Number: EMA/13161/2017

Orencia - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision