PIL — Lecavance
PIL labeling artefact for Lecanemabix in Belgium. Version 17.7. Language: de.
Artifact ID
LBL-027
Type
PIL
Product
Market
Belgium
Version
17.7
Language
de
Status
In Progress
Last Reviewed
2023-05-21
Included Statements (6)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-079 | PK | SmPC Section 4.2 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-10-16 |
| STMT-080 | Dosing | SmPC Section 4.1 | The recommended dose is 10 mg once daily administered orally.… | 2023-09-21 |
| STMT-081 | Efficacy | SmPC Section 4.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-07-08 |
| STMT-082 | Safety | SmPC Section 4.5 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-09-02 |
| STMT-083 | Safety | SmPC Section 4.2 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-03-30 |
| STMT-084 | Contraindication | Core Data Sheet | This product has been designated as an orphan medicine in the European Union.… | 2024-03-03 |
Change History
Updated section 4.4 — special warnings
Harmonisation to core label
Posology revision