EMEA-002999-PIP01-21 - 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/0521/2022
• PIP number:
  EMEA-002999-PIP01-21
• 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
• Contact for public enquiries:

  MSD Europe Belgium S.R.L.; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/12/2022

Decision

P/0521/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for live, attenuated, dengue virus, serotype 1 (DENV1), live, attenuated, chimeric dengue

AdoptedReference Number: EMA/915714/2022