MHRA paediatric investigation plan
Breyanzi (LISOCABTAGENE MARALEUCEL)
MHRA paediatric investigation plan MHRA-101630-PIP01-24-M01 (update) · Waiver
Key facts
| PIP number | MHRA-101630-PIP01-24-M01 (update) |
|---|---|
| Product names | Breyanzi |
| Active substances | LISOCABTAGENE MARALEUCEL |
| Therapeutic areas | Oncology |
| Conditions | Treatment of B-lymphoblastic leukaemia/lymphoma, Treatment of mature B-cell neoplasm |
| Decision | W: decision granting a waiver in all age groups for the listed condition(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: