PIL — Brexivance
PIL labeling artefact for Brextanib in Mexico. Version 16.5. Language: nl.
Artifact ID
LBL-049
Type
PIL
Product
Market
Mexico
Version
16.5
Language
nl
Status
In Progress
Last Reviewed
2023-10-23
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-145 | Contraindication | SmPC Section 5.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-08-08 |
| STMT-146 | Interaction | SmPC Section 5.2 | Patients should be advised not to drive or operate machinery if they experience … | 2023-10-02 |
| STMT-147 | Special Population | SmPC Section 5.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-05-15 |
| STMT-148 | Safety | SmPC Section 4.3 | This product has been designated as an orphan medicine in the European Union.… | 2024-01-18 |
| STMT-149 | Safety | SmPC Section 4.5 | The recommended dose is 10 mg once daily administered orally.… | 2023-07-24 |
| STMT-150 | Special Population | SmPC Section 4.4 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2024-02-09 |
| STMT-151 | Safety | Core Data Sheet | This product has been designated as an orphan medicine in the European Union.… | 2024-04-23 |
| STMT-152 | Safety | SmPC Section 4.3 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-07-18 |
| STMT-153 | Efficacy | SmPC Section 4.1 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2024-06-16 |
| STMT-154 | Dosing | SmPC Section 5.1 | Treatment should be initiated under the supervision of a physician experienced i… | 2022-12-17 |
Change History
New indication added
Posology revision
Section 4.8 ADR update
Section 4.8 ADR update
Interaction section update
Posology revision