EMEA-002555-PIP02-21 - paediatric investigation plan

Recombinant humanized anti-blood dendritic cell antigen 2 (BDCA2) monoclonal antibody (BIIB059)

Key facts

• Active Substance:
  Recombinant humanized anti-blood dendritic cell antigen 2 (BDCA2) monoclonal antibody (BIIB059)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0055/2022
• PIP number:
  EMEA-002555-PIP02-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of lupus erythematosus
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Biogen Netherlands 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:
  11/03/2022

Decision

P/0055/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant humanized anti-blood dendritic cell antigen 2.. (EMEA-002555-PIP02-21)

AdoptedReference Number: EMA/94153/2022