MHRA-100657-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BULEVIRTIDE
Invented Name
  • Hepcludex
  • Hepcludex
  • Myrcludex B
PIP Number MHRA-100657-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection
Therapeutic area
  • Gastroenterology-Hepatology
  • 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
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
04/10/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100657-PIP01-22-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BULEVIRTIDE.pdf
Published Date 15/07/2026