MHRA paediatric investigation plan
AGAMREE (Vamorolone)
MHRA paediatric investigation plan MHRA-100811-PIP01-22 · Modification
Key facts
| PIP number | MHRA-100811-PIP01-22 |
|---|---|
| Product names | AGAMREE |
| Active substances | Vamorolone |
| Therapeutic areas | Other: Neuromuscular Diseases |
| Conditions | Treatment of Duchenne muscular dystrophy |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| 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: