MHRA paediatric investigation plan
Gazyvaro (OBINUTUZUMAB)
MHRA paediatric investigation plan MHRA-100792-PIP01-22 · Agreement
Key facts
| PIP number | MHRA-100792-PIP01-22 |
|---|---|
| Product names | Gazyvaro |
| Active substances | OBINUTUZUMAB |
| Therapeutic areas | Oncology |
| Conditions | Prevention of cytokine release syndrome induced by anti CD20/CD3 antibodies |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Jun 30, 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: