MHRA paediatric investigation plan
Rozlytrek (ENTRECTINIB)
MHRA paediatric investigation plan MHRA-100166-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100166-PIP01-21-M01 (update) |
|---|---|
| Product names | Rozlytrek |
| Active substances | ENTRECTINIB |
| Therapeutic areas | Oncology |
| Conditions | Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms). |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Jul 29, 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: