MHRA-100291-PIP01-21

Key Facts

Active Substance
Active Substance:
  • imetelstat
Invented Name
Not yet available
PIP Number MHRA-100291-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of acute myeloid leukaemia
  • Treatment of Myelodysplastic Syndromes (MDS), including JMML
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Geron Corporation
  • Country United States
  • Tel 0016504737718
  • Email obloom@geron.com
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):imetelstat.pdf
Published Date 17/05/2022