MHRA paediatric investigation plan
Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316) (Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316))
MHRA paediatric investigation plan MHRA-100242-PIP01-21 · Agreement
Key facts
| PIP number | MHRA-100242-PIP01-21 |
|---|---|
| Active substances | Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316) |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of lower respiratory tract disease caused by respiratory syncytial virus. |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Oct 24, 2024 |
| 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: