PIL — Raredex
PIL labeling artefact for Raredimab in Switzerland. Version 13.4. Language: nl.
Artifact ID
LBL-039
Type
PIL
Product
Market
Switzerland
Version
13.4
Language
nl
Status
Pending
Last Reviewed
2023-07-10
Included Statements (9)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-115 | Contraindication | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2024-01-20 |
| STMT-116 | Safety | SmPC Section 4.5 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-07-26 |
| STMT-117 | Dosing | SmPC Section 5.1 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-12-17 |
| STMT-118 | Efficacy | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2022-11-22 |
| STMT-119 | Contraindication | SmPC Section 5.1 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2024-05-18 |
| STMT-120 | PK | SmPC Section 4.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-06-19 |
| STMT-121 | Safety | SmPC Section 4.1 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2024-02-19 |
| STMT-122 | Interaction | SmPC Section 4.5 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2024-06-14 |
| STMT-123 | PK | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2022-11-03 |
Change History
Posology revision
Posology revision
Posology revision
New indication added
Harmonisation to core label
Harmonisation to core label