Labeling — Cardivex
Labeling labeling artefact for Cardilostat in Japan. Version 7.8. Language: nl.
Artifact ID
LBL-003
Type
Labeling
Product
Market
Japan
Version
7.8
Language
nl
Status
Active
Last Reviewed
2023-10-21
Included Statements (3)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-007 | Special Population | SmPC Section 5.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-02-12 |
| STMT-008 | Dosing | SmPC Section 4.4 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-05-02 |
| STMT-009 | Dosing | Core Data Sheet | This product has been designated as an orphan medicine in the European Union.… | 2023-02-15 |
Change History