MHRA paediatric investigation plan
Flublok (Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype))
MHRA paediatric investigation plan MHRA-101492-PIP01-24 · Agreement
Key facts
| PIP number | MHRA-101492-PIP01-24 |
|---|---|
| Product names | Flublok |
| Active substances | Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype), Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype), Recombinant Influenza Hemagglutinin-strain B (RIV3) |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of influenza disease |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Compliance check outcome | Full |
| Published | Oct 3, 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: