EMEA-002730-PIP04-21-M01 - paediatric investigation plan

Exagamglogene autotemcel

Key facts

• Active Substance:
  Exagamglogene autotemcel
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0046/2023
• PIP number:
  EMEA-002730-PIP04-21-M01
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of beta-thalassemia intermedia and major
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Vertex Pharmaceuticals (Ireland) Limited

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/01/2023

Decision

P/0046/2023 : EMA decision of 24 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan for exagamglogene autotemcel (EMEA-002730-PIP04-21-M01)

Adopted