MHRA-100557-PIP01-22-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Hepatitis B (rDNA) surface antigen adjuvanted
Invented Name
  • HEPLISAV B
  • HEPLISAV-B
  • HEPLISAV-B
  • HEPLISAV B
PIP Number MHRA-100557-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of hepatitis B virus infection
Route(s) of administration
Route(s) of administration:
  • Intramuscular 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Hepatitis B (rDNA) surface antigen adjuvanted.pdf
Published Date 07/12/2022