EMA/PE/0000224202 - paediatric investigation plan

Dengue tetravalent vaccine (live, attenuated)

Key facts

• Invented name:
  Qdenga
• Active substance:
  Dengue tetravalent vaccine (live, attenuated)
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000224202
• PIP number:
  EMA/PE/0000224202
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Prevention of dengue fever
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000224202: EMA decision of 5 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dengue tetravalent vaccine (live, attenuated) (Qdenga)

Adopted Reference Number: EMADOC-1700519818-1793045