MHRA paediatric investigation plan
nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody) (nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody))
MHRA paediatric investigation plan MHRA-100067-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100067-PIP01-21-M01 (update) |
|---|---|
| Active substances | nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody) |
| Therapeutic areas | Infectious diseases, Vaccines |
| Conditions | Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV). |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Nov 3, 2021 |
| 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: