MHRA paediatric investigation plan
LIVMARLI (Maralixibat chloride)
MHRA paediatric investigation plan MHRA-100991-PIP01-23 · Modification
Key facts
| PIP number | MHRA-100991-PIP01-23 |
|---|---|
| Product names | LIVMARLI |
| Active substances | Maralixibat chloride |
| Therapeutic areas | Gastroenterology-Hepatology |
| Conditions | Treatment of progressive familial intrahepatic cholestasis (PFIC) |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Compliance check outcome | Partial |
| Published | Jan 30, 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: