EMEA-003592-PIP01-24 - paediatric investigation plan

gorilla adenovirus vector expressing HPV6 and HPV11 antigens (PRGN-2012)

Key facts

• Active substance:
  gorilla adenovirus vector expressing HPV6 and HPV11 antigens (PRGN-2012)
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0396/2024
• PIP number:
  EMEA-003592-PIP01-24
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of respiratory papillomatosis
• 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:
  06/12/2024
• Compliance check done:
  No

Decision

P/0396/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for gorilla adenovirus vector expressing HPV6 and HPV11 antigens (PRGN-2012), (EMEA-003592-PIP01-24)

Adopted Reference Number: EMA/534088/2024