MHRA paediatric investigation plan
Not available at present (leniolisib)
MHRA paediatric investigation plan MHRA-100075-PIP01-21 · Agreement
Key facts
| PIP number | MHRA-100075-PIP01-21 |
|---|---|
| Product names | Not available at present |
| Active substances | leniolisib |
| Therapeutic areas | Immunology -Rheumatology-Transplantation |
| Conditions | Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Nov 2, 2022 |
| 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: