Labeling — Verasol
Labeling labeling artefact for Verasenib in European Union. Version 5.4. Language: ko.
Artifact ID
LBL-032
Type
Labeling
Product
Market
European Union
Version
5.4
Language
ko
Status
Pending
Last Reviewed
2024-07-02
Included Statements (8)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-094 | Safety | SmPC Section 4.4 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-12-30 |
| STMT-095 | Efficacy | SmPC Section 4.5 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-11-20 |
| STMT-096 | Special Population | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-02-02 |
| STMT-097 | Dosing | SmPC Section 4.4 | The recommended dose is 10 mg once daily administered orally.… | 2023-05-30 |
| STMT-098 | Contraindication | SmPC Section 4.5 | The recommended dose is 10 mg once daily administered orally.… | 2023-05-06 |
| STMT-099 | Safety | SmPC Section 4.8 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-10-26 |
| STMT-100 | Dosing | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-05-09 |
| STMT-101 | Dosing | Core Data Sheet | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-08-09 |
Change History
Updated section 4.4 — special warnings
New indication added
Harmonisation to core label