MHRA paediatric investigation plan
Fabhalta (IPTACOPAN HYDROCHLORIDE MONOHYDRATE)
MHRA paediatric investigation plan MHRA-101711-PIP01-24-M01 (update) · Modification
Key facts
| PIP number | MHRA-101711-PIP01-24-M01 (update) |
|---|---|
| Product names | Fabhalta |
| Active substances | IPTACOPAN HYDROCHLORIDE MONOHYDRATE |
| Therapeutic areas | Other: Complement-driven renal disease |
| Conditions | Treatment of C3 glomerulopathy |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Compliance check outcome | Partial |
| Published | Feb 11, 2025 |
| 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: