MHRA paediatric investigation plan
Derivative of 3-phenyl-3H,4H,6H,7H-pyrano[3,4-d]imidazol-4-one (Derivative of 3-phenyl-3H,4H,6H,7H-pyrano[3,4-d]imidazol-4-one)
MHRA paediatric investigation plan MHRA-100446-PIP01-22 · Agreement
Key facts
| PIP number | MHRA-100446-PIP01-22 |
|---|---|
| Active substances | Derivative of 3-phenyl-3H,4H,6H,7H-pyrano[3,4-d]imidazol-4-one |
| Therapeutic areas | Uro-Nephrology |
| Conditions | Treatment of Chronic Kidney Disease |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Dec 19, 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: