MHRA paediatric investigation plan
Lojuxta hard capsule (Lomitapide)
MHRA paediatric investigation plan MHRA-100681-PIP01-22 · Modification
Key facts
| PIP number | MHRA-100681-PIP01-22 |
|---|---|
| Product names | Lojuxta hard capsule |
| Active substances | Lomitapide |
| Therapeutic areas | Other: Hypercholesterolaemia (HoFH) |
| Conditions | Treatment of (heterozygous or homozygous) familial hypercholesterolaemia |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Jun 30, 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: