EMEA-001665-PIP01-14-M06 - paediatric investigation plan

betibeglogene autotemcel

Key facts

• Invented name:
  Zynteglo
• Active substance:
  betibeglogene autotemcel
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0175/2022
• PIP number:
  EMEA-001665-PIP01-14-M06
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of β-thalassaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  13/05/2022
• Compliance check done:
  Nej

Decision

P/0175/2022 : EMA decision of 13 May 2022 on the refusal of a modification of an agreed paediatric investigation plan for betibeglogene autotemcel (Zynteglo), (EMEA-001665-PIP01-14-M06)

Adopted Reference Number: EMA/206734/2022