MHRA paediatric investigation plan
Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab) (Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab))
MHRA paediatric investigation plan MHRA-100301-PIP01-21 · Waiver
Key facts
| PIP number | MHRA-100301-PIP01-21 |
|---|---|
| Active substances | Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab ) |
| Therapeutic areas | Neurology |
| Conditions | Treatment of chronic inflammatory demyelinating polyradiculoneuropathy |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | May 19, 2022 |
| 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: