MHRA-100096-PIP01-21

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)
Invented Name
Not available at present
PIP Number MHRA-100096-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of dengue disease
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):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).pdf
Published Date 19/12/2023