EMEA-002856-PIP01-20 - paediatric investigation plan

recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8 (AK002)

Key facts

• Active substance:
  recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8 (AK002)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0277/2021
• PIP number:
  EMEA-002856-PIP01-20
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of eosinophilic gastrointestinal inflammatory disorders
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/07/2021
• Compliance check done:
  No

Decision

P/0277/2021: EMA decision of 8 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant monoclonal antibody...(EMEA-002856-PIP01-20)

Reference Number: EMA/359062/2021