Labeling — Duplexan
Labeling labeling artefact for Dupitumacon in Canada. Version 1.0. Language: fr.
Artifact ID
LBL-066
Type
Labeling
Product
Market
Canada
Version
1.0
Language
fr
Status
Submitted
Last Reviewed
2023-12-10
Included Statements (5)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-196 | Safety | SmPC Section 4.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-03-22 |
| STMT-197 | Contraindication | SmPC Section 5.1 | The recommended dose is 10 mg once daily administered orally.… | 2023-06-29 |
| STMT-198 | Efficacy | SmPC Section 5.2 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-03-25 |
| STMT-199 | Interaction | SmPC Section 4.3 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-11-12 |
| STMT-200 | Dosing | Core Data Sheet | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-04-23 |
Change History
Updated section 4.4 — special warnings
Interaction section update
Section 4.8 ADR update
Updated section 4.4 — special warnings
New indication added
Interaction section update