MHRA paediatric investigation plan
Vyvgar (efgartigimod alfa)
MHRA paediatric investigation plan MHRA-101265-PIP01-23 · Waiver
Key facts
| PIP number | MHRA-101265-PIP01-23 |
|---|---|
| Product names | Vyvgar, Vyvgart |
| Active substances | efgartigimod alfa |
| Therapeutic areas | Endocrinology-Gynaecology-Fertility-metabolism |
| Conditions | Treatment of thyroid eye disease |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Jun 24, 2024 |
| 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: