MHRA paediatric investigation plan
Livmarli (maralixibat chloride) ((4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride)
MHRA paediatric investigation plan MHRA-100775-PIP01-22-M02 (update) · Modification
Key facts
| PIP number | MHRA-100775-PIP01-22-M02 (update) |
|---|---|
| Product names | Livmarli (maralixibat chloride), LIVMARLI |
| Active substances | (4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride, Maralixibat chloride |
| Therapeutic areas | Gastroenterology-Hepatology |
| Conditions | Treatment of Alagille Syndrome (ALGS) |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Compliance check outcome | Full |
| Published | Aug 1, 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: