EMEA-001910-PIP03-20-M01 - paediatric investigation plan

Imetelstat

Key facts

• Active Substance:
  Imetelstat
• Therapeutic area:
  Oncology
• Decision number:
  P/0517/2022
• PIP number:
  EMEA-001910-PIP03-20-M01
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  • Treatment of acute myeloid leukemia
  • Treatment of myelodysplastic syndromes, including juvenile myelomonocytic leukemia
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Geron Corporation

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022

Decision

P/0517/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for imetelstat (EMEA- 001910-PIP03-20-M01)

AdoptedReference Number: EMA/911953/2022