MHRA paediatric investigation plan
Not available at present (DECITABINE)
MHRA paediatric investigation plan MHRA-101350-PIP01-24 · Agreement
Key facts
| PIP number | MHRA-101350-PIP01-24 |
|---|---|
| Product names | Not available at present |
| Active substances | DECITABINE, Tetrahydrouridine |
| Therapeutic areas | Haematology-Hemostaseology |
| Conditions | Treatment of sickle cell disease (SCD) |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Apr 8, 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: