MHRA paediatric investigation plan
Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451) (Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451))
MHRA paediatric investigation plan MHRA-100297-PIP01-21 · Modification
Key facts
| PIP number | MHRA-100297-PIP01-21 |
|---|---|
| Active substances | Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451) |
| Therapeutic areas | Dermatology |
| Conditions | Treatment of atopic dermatitis |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Feb 2, 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: