MHRA-101417-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Plozasiran (USAN)(synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues)
Invented Name
Redemplo
PIP Number MHRA-101417-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Familial chylomicronaemia syndrome (FCS)
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):Plozasiran (USAN)(synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues).pdf
Published Date 02/05/2025