EMEA-003219-PIP01-22 - paediatric investigation plan

inclacumab

Key facts

• Active substance:
  inclacumab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0545/2022
• PIP number:
  EMEA-003219-PIP01-22
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of sickle cell disease
• 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:
  30/12/2022
• Compliance check done:
  No

Decision

P/0545/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for inclacumab (EMEA-003219-PIP01-22)

Reference Number: EMA/876031/2022