EMEA-000118-PIP04-17 - paediatric investigation plan

abatacept

Key facts

• Invented name:
  • Orencia
  • Orencia
• Active substance:
  abatacept
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0183/2018
• PIP number:
  EMEA-000118-PIP04-17
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Solution for injection
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/06/2018
• Compliance check done:
  Ne

Decision

P/0183/2018: EMA decision of 22 June 2018 on the granting of a product specific waiver for abatacept (Orencia), (EMEA-000118-PIP04-17)

Adopted Reference Number: EMA/407702/2018