MHRA paediatric investigation plan
Nulibry (fosdenopterin)
MHRA paediatric investigation plan MHRA-101188-PIP01-23-M01 (update) · Modification
Key facts
| PIP number | MHRA-101188-PIP01-23-M01 (update) |
|---|---|
| Product names | Nulibry |
| Active substances | fosdenopterin |
| Therapeutic areas | Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products |
| Conditions | Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Dec 19, 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: