EMEA-002399-PIP01-18-M01 - paediatric investigation plan

bulevirtide

Key facts

• Invented name:
  Hepcludex
• Active substance:
  bulevirtide
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0270/2022
• PIP number:
  EMEA-002399-PIP01-18-M01
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of chronic hepatitis D infection
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002399-PIP01-18-M01
• Compliance opinion date:
  08/09/2023
• Compliance outcome:
  Positive

Decision

P/0270/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bulevirtide (Hepcludex) (EMEA-002399-PIP01-18-M01)

Adopted Reference Number: EMA/624977/2022