Labeling — Sacuvance
Labeling labeling artefact for Sacubitrivex in Saudi Arabia. Version 18.1. Language: nl.
Artifact ID
LBL-022
Type
Labeling
Product
Market
Saudi Arabia
Version
18.1
Language
nl
Status
Active
Last Reviewed
2023-11-21
Included Statements (9)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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 |
| STMT-068 | Special Population | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-07-15 |
| STMT-069 | Dosing | SmPC Section 4.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-05-01 |
| STMT-070 | Dosing | SmPC Section 4.5 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-03-07 |
| STMT-071 | Special Population | SmPC Section 5.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-07-28 |
| STMT-072 | Special Population | Core Data Sheet | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-11-22 |
Change History
Section 4.8 ADR update