SmPC — Erenvex
SmPC labeling artefact for Erenumabix in Argentina. Version 16.8. Language: nl.
Artifact ID
LBL-050
Type
SmPC
Product
Market
Argentina
Version
16.8
Language
nl
Status
Active
Last Reviewed
2023-09-21
Included Statements (6)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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 |
Change History
New indication added
Interaction section update
Posology revision
Section 4.8 ADR update
Harmonisation to core label