PIL — Brexivance
PIL labeling artefact for Brextanib in Mexico. Version 16.4. Language: nl.
Artifact ID
LBL-019
Type
PIL
Product
Market
Mexico
Version
16.4
Language
nl
Status
Active
Last Reviewed
2024-03-01
Included Statements (3)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-055 | Dosing | SmPC Section 4.1 | This product has been designated as an orphan medicine in the European Union.… | 2023-11-27 |
| STMT-056 | Special Population | SmPC Section 4.5 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-03-29 |
| STMT-057 | PK | SmPC Section 4.3 | This product has been designated as an orphan medicine in the European Union.… | 2023-10-13 |
Change History
Interaction section update
Section 4.8 ADR update
Harmonisation to core label
Updated section 4.4 — special warnings