MHRA paediatric investigation plan
efgartigimod alfa (efgartigimod alfa)
MHRA paediatric investigation plan MHRA-100513-PIP01-22 · Agreement
Key facts
| PIP number | MHRA-100513-PIP01-22 |
|---|---|
| Active substances | efgartigimod alfa |
| Therapeutic areas | Immunology -Rheumatology-Transplantation |
| Conditions | Treatment of dermatomyositis, Treatment of immune-mediated necrotizing myopathy, Treatment of polymyositis (including antisynthetase syndrome) |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| 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: