MHRA-101336-PIP01-24-M01 (update)

Key Facts

Active Substance
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 1 SURFACE PROTEINS LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 3 SURFACE PROTEINS LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 4 SURFACE PROTEINS LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 LIVE ATTENUATED
Invented Name
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga powder and solvent for solution for injection
  • Qdenga powder and solvent for solution for injection in pre-filled syringe
PIP Number MHRA-101336-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for solution for injection
Therapeutic area
Conditions / Indications
Conditions / Indications:
  • Prevention of dengue fever
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 1 SURFACE PROTEINS LIVE ATTENUATEDDENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 3 SURFACE PROTEINS LIVE ATTENUATEDDENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 4 SURFACE PROTEINS LIVE ATTENUATEDDENGUE VIRUS SEROTYPE 2 LIVE ATTENUATED.pdf
Published Date 24/06/2024