MHRA paediatric investigation plan
Kymriah 1.2 x 10^6 - 6 x 10^8 cells dispersion for infusion (TISAGENLECLEUCEL)
MHRA paediatric investigation plan MHRA-100711-PIP01-22-M01 (update) · Modification
Key facts
| PIP number | MHRA-100711-PIP01-22-M01 (update) |
|---|---|
| Product names | Kymriah 1.2 x 10^6 - 6 x 10^8 cells dispersion for infusion, Kymriah, Kymriah 1.2 x 106 - 6 x 108 cells dispersion for infusion |
| Active substances | TISAGENLECLEUCEL |
| Therapeutic areas | Oncology |
| Conditions | Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | May 25, 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: