MHRA paediatric investigation plan
Bavencio (AVELUMAB)
MHRA paediatric investigation plan MHRA-100238-PIP01-21-M02 (update) · Modification
Key facts
| PIP number | MHRA-100238-PIP01-21-M02 (update) |
|---|---|
| Product names | Bavencio |
| Active substances | AVELUMAB |
| Therapeutic areas | Oncology |
| Conditions | Treatment of malignant neoplasms of the central nervous system, Treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms), Treatment of malignant neoplasms of the lymphoid tissue. |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Nov 29, 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: