MHRA paediatric investigation plan
Actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH) (Actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH))
MHRA paediatric investigation plan MHRA-101525-PIP01-24 · Waiver
Key facts
| PIP number | MHRA-101525-PIP01-24 |
|---|---|
| Active substances | Actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH) |
| Therapeutic areas | Oncology |
| Conditions | Treatment of PSMA-expressing prostate cancer |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Jan 6, 2025 |
| 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: