EMEA-002999-PIP01-21-M01 - 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:
  Vaccines
• Decision number:
  P/0165/2024
• PIP number:
  EMEA-002999-PIP01-21-M01
• 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:
  06/05/2024

Decision

P/0165/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for live, attenuated, dengue virus ... (EMEA-002999-PIP01-21-M01)

Reference Number: EMA/176734/2024