MHRA-100521-PIP01-22-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Evinacumab
Invented Name
  • Evkeeza
  • Evkeeza
  • Evkeeza
PIP Number MHRA-100521-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of elevated cholesterol
Route(s) of administration
Route(s) of administration:
  • intravenous
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Evinacumab.pdf
Published Date 29/07/2022