MHRA paediatric investigation plan
TAKHZYRO (LANADELUMAB)
MHRA paediatric investigation plan MHRA-100832-PIP01-23-M01 (update) · Waiver
Key facts
| PIP number | MHRA-100832-PIP01-23-M01 (update) |
|---|---|
| Product names | TAKHZYRO |
| Active substances | LANADELUMAB |
| Therapeutic areas | Other: Genetic disease |
| Conditions | Prevention of attacks of idiopathic non-histaminergic angioedema (INHA). |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Aug 24, 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: