MHRA paediatric investigation plan
RoActemra (TOCILIZUMAB)
MHRA paediatric investigation plan MHRA-100160-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100160-PIP01-21-M01 (update) |
|---|---|
| Product names | RoActemra |
| Active substances | TOCILIZUMAB |
| Therapeutic areas | Immunology -Rheumatology-Transplantation |
| Conditions | Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Dec 17, 2021 |
| 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: