Labeling — Duplexan
Labeling labeling artefact for Dupitumacon in Canada. Version 13.9. Language: ko.
Artifact ID
LBL-036
Type
Labeling
Product
Market
Canada
Version
13.9
Language
ko
Status
Approved
Last Reviewed
2024-06-19
Included Statements (5)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-106 | Safety | SmPC Section 4.4 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-02-26 |
| STMT-107 | Contraindication | SmPC Section 4.5 | The recommended dose is 10 mg once daily administered orally.… | 2024-01-10 |
| STMT-108 | Efficacy | SmPC Section 4.1 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-07-25 |
| STMT-109 | PK | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-01-03 |
| STMT-110 | Contraindication | SmPC Section 4.4 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-02-14 |
Change History
Posology revision
Harmonisation to core label
New indication added
New indication added
Interaction section update