EMEA-002702-PIP01-19 - paediatric investigation plan

Dapirolizumab pegol

Key facts

• Active Substance:
  Dapirolizumab pegol
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0439/2020
• PIP number:
  EMEA-002702-PIP01-19
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  UCB Biopharma SRL

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/12/2020

Decision

P/0439/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dapirolizumab pegol (EMEA-002702-PIP01-19)

AdoptedReference Number: EMA/599324/2020