EMEA-002004-PIP01-16 - paediatric investigation plan

atacicept

Key facts

• Active substance:
  atacicept
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0249/2017
• PIP number:
  EMEA-002004-PIP01-16
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  05/09/2017
• Compliance check done:
  No

Decision

P/0249/2017: EMA decision of 5 September 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atacicept (EMEA-002004-PIP01-16)

Adopted Reference Number: EMA/495986/2017