MHRA paediatric investigation plan
Ultomiris (Ravulizumab (ALXN1210))
MHRA paediatric investigation plan MHRA-101204-PIP01-23 · Waiver
Key facts
| PIP number | MHRA-101204-PIP01-23 |
|---|---|
| Product names | Ultomiris |
| Active substances | Ravulizumab (ALXN1210) |
| Therapeutic areas | Uro-Nephrology |
| Conditions | Prevention of kidney injury in high-risk patients with chronic kidney disease undergoing cardiopulmonary bypass |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Oct 3, 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: