EMEA-003082-PIP01-21 - paediatric investigation plan

bepirovirsen

Key facts

• Active substance:
  bepirovirsen
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0254/2022
• PIP number:
  EMEA-003082-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic hepatitis B infection
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/07/2022
• Compliance check done:
  No

Decision

P/254/2022 : EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bepirovirsen (EMEA-003082-PIP01-21)

Adopted Reference Number: EMA/579397/2022