Labeling — Ocluvance
Labeling labeling artefact for Kcluximab in United States. Version 8.3. Language: ko.
Artifact ID
LBL-001
Type
Labeling
Product
Market
United States
Version
8.3
Language
ko
Status
Approved
Last Reviewed
2024-07-05
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-001 | Interaction | SmPC Section 4.5 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-10-20 |
| STMT-002 | PK | SmPC Section 4.1 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-12-05 |
| STMT-003 | Special Population | SmPC Section 4.1 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-11-19 |
| STMT-004 | PK | Core Data Sheet | Fertility studies in animals have not shown any adverse effects on fertility.… | 2024-03-19 |
| STMT-005 | Safety | SmPC Section 5.1 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-09-28 |
| STMT-006 | Interaction | SmPC Section 4.8 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-04-22 |
| STMT-007 | Special Population | SmPC Section 5.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-02-12 |
| STMT-008 | Dosing | SmPC Section 4.4 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-05-02 |
| STMT-009 | Dosing | Core Data Sheet | This product has been designated as an orphan medicine in the European Union.… | 2023-02-15 |
| STMT-010 | Interaction | SmPC Section 4.2 | Patients should be advised not to drive or operate machinery if they experience … | 2024-05-24 |
Change History
Section 4.8 ADR update
Updated section 4.4 — special warnings