MHRA-100919-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Bepirovirsen
Invented Name
Not yet available
PIP Number MHRA-100919-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic hepatitis B infection
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • GlaxoSmithKline UK Limited
  • Country United Kingdom
  • Tel +4402080475000
  • Email oax52639@gsk.com
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):Bepirovirsen.pdf
Published Date 19/12/2023