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

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
Yes
Compliance Check Decision Date
Compliance opinion date
11/07/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100521-PIP01-22-M01-C1

Decision Document

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