IFU — Lecavance
IFU labeling artefact for Lecanemabix in Belgium. Version 18.6. Language: it.
Artifact ID
LBL-057
Type
IFU
Product
Market
Belgium
Version
18.6
Language
it
Status
Pending
Last Reviewed
2024-05-02
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-169 | Contraindication | SmPC Section 4.3 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-03-08 |
| STMT-170 | Safety | SmPC Section 4.5 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2022-11-08 |
| STMT-171 | Dosing | SmPC Section 4.1 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-02-23 |
| STMT-172 | Efficacy | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-08-15 |
| STMT-173 | Contraindication | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-02-18 |
| STMT-174 | Interaction | SmPC Section 4.1 | The recommended dose is 10 mg once daily administered orally.… | 2024-04-04 |
| STMT-175 | Safety | SmPC Section 4.5 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-03-25 |
| STMT-176 | Dosing | SmPC Section 4.2 | Patients should be advised not to drive or operate machinery if they experience … | 2022-12-17 |
| STMT-177 | Dosing | SmPC Section 5.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-06-17 |
| STMT-178 | Interaction | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-01-16 |
Change History
Interaction section update
Harmonisation to core label