MHRA paediatric investigation plan
Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain (Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain)
MHRA paediatric investigation plan MHRA-100237-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100237-PIP01-21-M01 (update) |
|---|---|
| Product names | Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (called Efluelda throughout rest of Europe), Efluelda, Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose |
| Active substances | Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain, Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage), Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage) |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of influenza infection |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Jul 29, 2022 |
| 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: