MHRA paediatric investigation plan
Anti-C1s Humanized IgG4 Monoclonal Antibody (Anti-C1s Humanized IgG4 Monoclonal Antibody)
MHRA paediatric investigation plan MHRA-100556-PIP01-22 · Waiver
Key facts
| PIP number | MHRA-100556-PIP01-22 |
|---|---|
| Active substances | Anti-C1s Humanized IgG4 Monoclonal Antibody |
| Therapeutic areas | Neurology, Immunology -Rheumatology-Transplantation, Haematology-Hemostaseology |
| Conditions | Treatment of chronic inflammatory demyelinating polyradiculoneuropathy |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Dec 7, 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: