MHRA-102590-PIP01-26-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Lerodalcibep
Invented Name
  • LEROCHOL
  • LYROKAUL
PIP Number MHRA-102590-PIP01-26-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
  • Treatment of hypercholesterolaemia
  • Treatment of mixed dyslipidaemia
Route(s) of administration
Route(s) of administration:
  • Subcutaneous 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 opinion date
03/08/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102590-PIP01-26-M01-C1

Decision Document

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