MHRA paediatric investigation plan
Axumin (FLUCICLOVINE (18F))
MHRA paediatric investigation plan MHRA-100632-PIP01-22-M01 (update) · Waiver
Key facts
| PIP number | MHRA-100632-PIP01-22-M01 (update) |
|---|---|
| Product names | Axumin |
| Active substances | FLUCICLOVINE (18F) |
| Therapeutic areas | Diagnostic, Oncology |
| Conditions | Diagnosis of amino acid metabolism in solid malignant tumours |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| 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: