MHRA-100637-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus
Invented Name
Not available at present
PIP Number MHRA-100637-PIP01-22
Pharmaceutical form(s)
  • Solution for injection
  • Age-appropriate dosage form for parenteral use.
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic hepatitis D infection
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):Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNAoligonucleotides that are directed against hepatitis B virus.pdf
Published Date 25/05/2023