MHRA paediatric investigation plan
FLUCELVAX TETRA (INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN)
MHRA paediatric investigation plan MHRA-100177-PIP01-21-M02 (update) · Modification
Key facts
| PIP number | MHRA-100177-PIP01-21-M02 (update) |
|---|---|
| Product names | FLUCELVAX TETRA, Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe |
| Active substances | INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN, INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN, INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN, INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of Influenza |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Compliance check outcome | Partial |
| Published | Aug 24, 2023 |
| 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: