MHRA paediatric investigation plan
fordadistrogene movaparvovec (Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene)
MHRA paediatric investigation plan MHRA-100126-PIP01-21-M01 (update) · Agreement
Key facts
| PIP number | MHRA-100126-PIP01-21-M01 (update) |
|---|---|
| Product names | fordadistrogene movaparvovec |
| Active substances | Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene |
| Therapeutic areas | Neurology |
| Conditions | Duchenne Muscular Dystrophy |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Jun 15, 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: