EMEA-003085-PIP01-21 - paediatric investigation plan

Sibeprenlimab

Key facts

• Active Substance:
  Sibeprenlimab
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0232/2022
• PIP number:
  EMEA-003085-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of primary immunoglobulin A nephropathy
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Otsuka Pharmaceutical Netherlands B.V.

  [e-mail] ; [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/07/2022

Decision

P/0232/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sibeprenlimab (EMEA-003085-PIP01-21)

AdoptedReference Number: EMA/575972/2022