IFU — Nepricor
IFU labeling artefact for Neprilozone in China. Version 1.9. Language: sv.
Artifact ID
LBL-034
Type
IFU
Product
Market
China
Version
1.9
Language
sv
Status
Pending
Last Reviewed
2024-01-02
Included Statements (8)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-100 | Dosing | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-05-09 |
| STMT-101 | Dosing | Core Data Sheet | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-08-09 |
| STMT-102 | Special Population | SmPC Section 4.5 | Patients should be advised not to drive or operate machinery if they experience … | 2023-09-07 |
| STMT-103 | Safety | SmPC Section 4.1 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-10-09 |
| STMT-104 | Dosing | SmPC Section 5.1 | This product has been designated as an orphan medicine in the European Union.… | 2024-05-25 |
| STMT-105 | Contraindication | Core Data Sheet | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-01-08 |
| STMT-106 | Safety | SmPC Section 4.4 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-02-26 |
| STMT-107 | Contraindication | SmPC Section 4.5 | The recommended dose is 10 mg once daily administered orally.… | 2024-01-10 |
Change History
Section 4.8 ADR update
Section 4.8 ADR update