MHRA paediatric investigation plan
Dojolvi (triheptanoin)
MHRA paediatric investigation plan MHRA-100654-PIP01-22 · Agreement
Key facts
| PIP number | MHRA-100654-PIP01-22 |
|---|---|
| Product names | Dojolvi |
| Active substances | triheptanoin |
| Therapeutic areas | Endocrinology-Gynaecology-Fertility-metabolism |
| Conditions | Treatment of long-chain fatty acid oxidation disorders (LC-FAOD) |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Compliance check outcome | Partial |
| Published | Aug 15, 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: