EMEA-002815-PIP01-20 - paediatric investigation plan

Rozibafusp alfa

Key facts

• Active Substance:
  Rozibafusp alfa
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0100/2021
• PIP number:
  EMEA-002815-PIP01-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Amgen Europe B.V.

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  17/03/2021

Decision

P/0100/2021 : EMA decision of 17 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rozibafusp alfa (EMEA-002815-PIP01-20)

Reference Number: EMA/71537/2021