SmPC — Raredex
SmPC labeling artefact for Raredimab in Switzerland. Version 5.9. Language: de.
Artifact ID
LBL-009
Type
SmPC
Product
Market
Switzerland
Version
5.9
Language
de
Status
In Progress
Last Reviewed
2023-10-11
Included Statements (3)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-025 | Safety | SmPC Section 4.5 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-05-21 |
| STMT-026 | Contraindication | SmPC Section 4.8 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-06-16 |
| STMT-027 | Dosing | SmPC Section 4.5 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-04-05 |
Change History
Posology revision