IFU — Duplexan
IFU labeling artefact for Dupitumacon in Canada. Version 12.4. Language: en.
Artifact ID
LBL-006
Type
IFU
Product
Market
Canada
Version
12.4
Language
en
Status
Pending
Last Reviewed
2023-12-01
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-016 | PK | SmPC Section 4.4 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-06-18 |
| STMT-017 | Interaction | SmPC Section 4.3 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2022-11-16 |
| STMT-018 | Safety | SmPC Section 4.1 | The recommended dose is 10 mg once daily administered orally.… | 2022-11-06 |
| STMT-019 | PK | SmPC Section 4.3 | This product has been designated as an orphan medicine in the European Union.… | 2023-09-11 |
| STMT-020 | Safety | SmPC Section 4.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2024-03-07 |
| STMT-021 | Safety | Core Data Sheet | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-09-07 |
| STMT-022 | PK | SmPC Section 4.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-11-16 |
| STMT-023 | Safety | Core Data Sheet | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-05-20 |
| STMT-024 | Safety | SmPC Section 4.5 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-05-21 |
| STMT-025 | Safety | SmPC Section 4.5 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-05-21 |
Change History
New indication added
Updated section 4.4 — special warnings
Posology revision