MHRA paediatric investigation plan
Radicava (Edaravone)
MHRA paediatric investigation plan MHRA-100055-PIP01-21 · Waiver
Key facts
| PIP number | MHRA-100055-PIP01-21 |
|---|---|
| Product names | Radicava, Radicut |
| Active substances | Edaravone |
| Therapeutic areas | Neurology |
| Conditions | Treatment of Amyotrophic lateral sclerosis |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Nov 3, 2021 |
| 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: