SmPC — Erenvex
SmPC labeling artefact for Erenumabix in Argentina. Version 14.8. Language: nl.
Artifact ID
LBL-020
Type
SmPC
Product
Market
Argentina
Version
14.8
Language
nl
Status
Approved
Last Reviewed
2024-07-06
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-058 | Safety | SmPC Section 4.4 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-05-12 |
| STMT-059 | Safety | SmPC Section 4.5 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-11-17 |
| STMT-060 | PK | SmPC Section 4.4 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2022-12-14 |
| STMT-061 | Contraindication | SmPC Section 4.4 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2024-02-24 |
| STMT-062 | Contraindication | SmPC Section 4.3 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-09-26 |
| STMT-063 | Interaction | SmPC Section 5.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2024-03-28 |
| STMT-064 | Safety | SmPC Section 4.3 | Patients should be advised not to drive or operate machinery if they experience … | 2023-09-24 |
| STMT-065 | Interaction | SmPC Section 4.8 | This product has been designated as an orphan medicine in the European Union.… | 2023-08-21 |
| STMT-066 | Contraindication | SmPC Section 4.3 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2022-11-05 |
| STMT-067 | Safety | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-11-21 |
Change History