MHRA paediatric investigation plan
Opdualag (NIVOLUMAB)
MHRA paediatric investigation plan MHRA-101315-PIP01-23 · Waiver
Key facts
| PIP number | MHRA-101315-PIP01-23 |
|---|---|
| Product names | Opdualag |
| Active substances | NIVOLUMAB, relatlimab |
| Therapeutic areas | Oncology |
| Conditions | Treatment of all conditions in the category of malignant neoplasms (except nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms and melanoma) |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Oct 3, 2024 |
| 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: