Labeling — Crizomax
Labeling labeling artefact for Crizotinabex in Austria. Version 9.2. Language: pl.
Artifact ID
LBL-058
Type
Labeling
Product
Market
Austria
Version
9.2
Language
pl
Status
In Progress
Last Reviewed
2024-04-09
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-172 | Efficacy | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-08-15 |
| STMT-173 | Contraindication | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-02-18 |
| STMT-174 | Interaction | SmPC Section 4.1 | The recommended dose is 10 mg once daily administered orally.… | 2024-04-04 |
| STMT-175 | Safety | SmPC Section 4.5 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-03-25 |
| STMT-176 | Dosing | SmPC Section 4.2 | Patients should be advised not to drive or operate machinery if they experience … | 2022-12-17 |
| STMT-177 | Dosing | SmPC Section 5.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-06-17 |
| STMT-178 | Interaction | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-01-16 |
| STMT-179 | Efficacy | SmPC Section 4.2 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2022-12-28 |
| STMT-180 | Special Population | Core Data Sheet | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2024-04-17 |
| STMT-181 | PK | SmPC Section 4.3 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-02-25 |
Change History
New indication added
Interaction section update