Labeling — Verasol
Labeling labeling artefact for Verasenib in European Union. Version 1.2. Language: de.
Artifact ID
LBL-002
Type
Labeling
Product
Market
European Union
Version
1.2
Language
de
Status
Approved
Last Reviewed
2024-03-10
Included Statements (7)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-004 | PK | Core Data Sheet | Fertility studies in animals have not shown any adverse effects on fertility.… | 2024-03-19 |
| STMT-005 | Safety | SmPC Section 5.1 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-09-28 |
| STMT-006 | Interaction | SmPC Section 4.8 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-04-22 |
| 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 |
| STMT-010 | Interaction | SmPC Section 4.2 | Patients should be advised not to drive or operate machinery if they experience … | 2024-05-24 |
Change History
Updated section 4.4 — special warnings
Harmonisation to core label
Posology revision
Section 4.8 ADR update
New indication added