MHRA paediatric investigation plan
Qdenga (DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 1 SURFACE PROTEINS LIVE ATTENUATED)
MHRA paediatric investigation plan MHRA-101336-PIP01-24-M02 (update) · Modification
Key facts
| PIP number | MHRA-101336-PIP01-24-M02 (update) |
|---|---|
| Product names | Qdenga, Qdenga powder and solvent for solution for injection, Qdenga powder and solvent for solution for injection in pre-filled syringe |
| Active substances | DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 1 SURFACE PROTEINS LIVE ATTENUATED, DENGUE VIRUS SEROTYPE 2 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 |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of dengue fever |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Apr 8, 2025 |
| MHRA record | cms.mhra.gov.uk |
About MHRA paediatric investigation plans
A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.
Source: UK Medicines and Healthcare products Regulatory Agency (MHRA). Contains public sector information licensed under the Open Government Licence v3.0 · Source date: