SmPC — Ocluvance
SmPC labeling artefact for Kcluximab in United States. Version 17.0. Language: zh.
Artifact ID
LBL-031
Type
SmPC
Product
Market
United States
Version
17.0
Language
zh
Status
In Progress
Last Reviewed
2023-11-19
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-091 | PK | Core Data Sheet | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-04-14 |
| STMT-092 | PK | SmPC Section 4.4 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-02-17 |
| STMT-093 | Efficacy | SmPC Section 5.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-03-08 |
| 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 |
Change History
Section 4.8 ADR update
New indication added
Updated section 4.4 — special warnings
Harmonisation to core label