SmPC — Cardivex
SmPC labeling artefact for Cardilostat in Japan. Version 9.0. Language: es.
Artifact ID
LBL-033
Type
SmPC
Product
Market
Japan
Version
9.0
Language
es
Status
Pending
Last Reviewed
2023-11-07
Included Statements (4)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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
Interaction section update
Updated section 4.4 — special warnings
Section 4.8 ADR update
Section 4.8 ADR update