MHRA-100211-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • VOLANESORSEN SODIUM
Invented Name
Waylivra 285 mg solution for injection in pre-filled syringe
PIP Number MHRA-100211-PIP01-21-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Familial chylomicronemia syndrome (FCS)
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):VOLANESORSEN SODIUM.pdf
Published Date 10/04/2026