MHRA paediatric investigation plan
fidanacogene elaparvovec (fidanacogene elaparvovec)
MHRA paediatric investigation plan MHRA-100451-PIP01-22-M01 (update) · Modification
Key facts
| PIP number | MHRA-100451-PIP01-22-M01 (update) |
|---|---|
| Active substances | fidanacogene elaparvovec |
| Therapeutic areas | Haematology-Hemostaseology |
| Conditions | Treatment of congenital factor IX deficiency (haemophilia B) |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Feb 2, 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: