MHRA paediatric investigation plan
INAQOVI (CEDAZURIDINE)
MHRA paediatric investigation plan MHRA-100635-PIP02-24 · Agreement
Key facts
| PIP number | MHRA-100635-PIP02-24 |
|---|---|
| Product names | INAQOVI, INQOVI, Inqovi 35/100 |
| Active substances | CEDAZURIDINE, DECITABINE |
| Therapeutic areas | Haematology-Hemostaseology, Oncology |
| Conditions | Treatment of myelodysplastic syndromes, including juvenile myelomonocytic leukaemia |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Oct 28, 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: