Labeling — Cardivex
Labeling labeling artefact for Cardilostat in Japan. Version 1.9. Language: fr.
Artifact ID
LBL-063
Type
Labeling
Product
Market
Japan
Version
1.9
Language
fr
Status
Active
Last Reviewed
2024-05-14
Included Statements (4)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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
Harmonisation to core label
Interaction section update
Harmonisation to core label