MHRA paediatric investigation plan
Human IgG1 monoclonal antibody targeting amyloid transthyretin (Human IgG1 monoclonal antibody targeting amyloid transthyretin)
MHRA paediatric investigation plan MHRA-101694-PIP01-24 · Waiver
Key facts
| PIP number | MHRA-101694-PIP01-24 |
|---|---|
| Active substances | Human IgG1 monoclonal antibody targeting amyloid transthyretin |
| Therapeutic areas | Neurology, Cardiovascular Diseases |
| Conditions | Treatment of transthyretin-mediated amyloidosis |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Apr 8, 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: