Labeling — Nepricor
Labeling labeling artefact for Neprilozone in China. Version 19.9. Language: en.
Artifact ID
LBL-004
Type
Labeling
Product
Market
China
Version
19.9
Language
en
Status
Pending
Last Reviewed
2023-08-11
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-010 | Interaction | SmPC Section 4.2 | Patients should be advised not to drive or operate machinery if they experience … | 2024-05-24 |
| STMT-011 | PK | SmPC Section 4.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2024-04-25 |
| STMT-012 | Efficacy | Core Data Sheet | The recommended dose is 10 mg once daily administered orally.… | 2024-04-18 |
| STMT-013 | Special Population | SmPC Section 4.3 | Patients should be advised not to drive or operate machinery if they experience … | 2024-04-25 |
| STMT-014 | Contraindication | SmPC Section 4.5 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-04-05 |
| STMT-015 | Contraindication | SmPC Section 5.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2024-01-04 |
| STMT-016 | PK | SmPC Section 4.4 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-06-18 |
| STMT-017 | Interaction | SmPC Section 4.3 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2022-11-16 |
| STMT-018 | Safety | SmPC Section 4.1 | The recommended dose is 10 mg once daily administered orally.… | 2022-11-06 |
| STMT-019 | PK | SmPC Section 4.3 | This product has been designated as an orphan medicine in the European Union.… | 2023-09-11 |
Change History
New indication added
Section 4.8 ADR update