MHRA-101488-PIP01-24-M02 (update)

Key Facts

Active Substance
Active Substance:
  • Etavopivat
Invented Name
Not yet available
PIP Number MHRA-101488-PIP01-24-M02 (update)
Pharmaceutical form(s)
  • Tablet
  • Granules
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of sickle cell disease
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-101488-PIP01-24-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Etavopivat.pdf
Published Date 04/09/2026