MHRA paediatric investigation plan
Not yet available in the United Kingdom (Ogsiveo in the United States and European Union). (nirogacestat hydrobromide)
MHRA paediatric investigation plan MHRA-101400-PIP01-24 · Agreement
Key facts
| PIP number | MHRA-101400-PIP01-24 |
|---|---|
| Product names | Not yet available in the United Kingdom (Ogsiveo in the United States and European Union)., Ogsiveo |
| Active substances | nirogacestat hydrobromide |
| Therapeutic areas | Oncology |
| Conditions | Treatment of soft tissue sarcoma |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Oct 3, 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: