EMEA-003392-PIP01-23 - paediatric investigation plan

broadly neutralizing anti-HIV human monoclonal antibody (VH3810109)

Key facts

• Active substance:
  broadly neutralizing anti-HIV human monoclonal antibody (VH3810109)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0505/2023
• PIP number:
  EMEA-003392-PIP01-23
• Pharmaceutical form(s):
  Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0505/2023: EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and of a waiver for broadly neutralizing anti-HIV human monoclonal antibody (VH3810109)(EMEA-003392-PIP01-23)

Adopted Reference Number: EMA/528359/2023