PIL — Ocluvance
PIL labeling artefact for Kcluximab in United States. Version 15.4. Language: nl.
Artifact ID
LBL-061
Type
PIL
Product
Market
United States
Version
15.4
Language
nl
Status
Approved
Last Reviewed
2023-11-04
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-181 | PK | SmPC Section 4.3 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-02-25 |
| STMT-182 | Safety | SmPC Section 4.1 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-09-28 |
| STMT-183 | Contraindication | SmPC Section 4.8 | Patients should be advised not to drive or operate machinery if they experience … | 2023-06-13 |
| STMT-184 | Dosing | Core Data Sheet | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-05-20 |
| STMT-185 | Interaction | SmPC Section 5.1 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-11-01 |
| STMT-186 | Special Population | SmPC Section 4.1 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-01-02 |
| STMT-187 | PK | SmPC Section 4.3 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2022-12-10 |
| STMT-188 | PK | SmPC Section 5.1 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-12-23 |
| STMT-189 | Interaction | SmPC Section 4.8 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-11-21 |
| STMT-190 | Safety | SmPC Section 4.1 | Patients should be advised not to drive or operate machinery if they experience … | 2024-04-22 |
Change History
Section 4.8 ADR update
Interaction section update