Labeling — Verasol
Labeling labeling artefact for Verasenib in European Union. Version 7.1. Language: ja.
Artifact ID
LBL-062
Type
Labeling
Product
Market
European Union
Version
7.1
Language
ja
Status
Active
Last Reviewed
2023-08-07
Included Statements (5)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-184 | Dosing | Core Data Sheet | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-05-20 |
| STMT-185 | Interaction | SmPC Section 5.1 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-11-01 |
| STMT-186 | Special Population | SmPC Section 4.1 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-01-02 |
| 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 |
Change History
New indication added
Harmonisation to core label
New indication added