MHRA paediatric investigation plan
Piqray (ALPELISIB)
MHRA paediatric investigation plan MHRA-100806-PIP01-22 · Waiver
Key facts
| PIP number | MHRA-100806-PIP01-22 |
|---|---|
| Product names | Piqray |
| Active substances | ALPELISIB |
| Therapeutic areas | Oncology |
| Conditions | Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours), Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours), Treatment of Peritoneal cancer (excluding blastomas and sarcomas). |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Aug 24, 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: