MHRA paediatric investigation plan
Isoprotrace (GOZETOTIDE)
MHRA paediatric investigation plan MHRA-101737-PIP01-24 · Waiver
Key facts
| PIP number | MHRA-101737-PIP01-24 |
|---|---|
| Product names | Isoprotrace, Isoprotrace 10 microgram, kit voor radiofarmaceutisch preparaat, Isoprotrace 10 Mikrogramm Kit für ein radioaktives Arzneimittel |
| Active substances | GOZETOTIDE |
| Therapeutic areas | Diagnostic, Oncology |
| Conditions | Visualisation of prostate specific membrane antigen in prostate cancer |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Feb 11, 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: