EMA/PE/0000241641 - paediatric investigation plan

Live, attenuated, dengue virus, serotype 1 (DENV1)

live, attenuated, chimeric dengue virus, serotype 2 (DENV2)

Live, attenuated, dengue virus, serotype 3 (DENV3)

Live, attenuated, dengue virus, serotype 4 (DENV4)

Key facts

• Active substance:
  • Live, attenuated, dengue virus, serotype 1 (DENV1)
  • live, attenuated, chimeric dengue virus, serotype 2 (DENV2)
  • Live, attenuated, dengue virus, serotype 3 (DENV3)
  • Live, attenuated, dengue virus, serotype 4 (DENV4)
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000241641
• PIP number:
  EMA/PE/0000241641
• Pharmaceutical form(s):
  Powder and solvent for concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of dengue disease
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/06/2025
• Compliance check done:
  Не

Decision

EMA/PE/0000241641 : EMA decision of 12 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for Live, attenuated, dengue virus, serotype 1 (DENV1) / serotype 2 (DENV2) / serotype 3 (DENV3) / serotype 4 (DENV4)

Adopted Reference Number: EMADOC-1700519818-2189819