Labeling — Nepricor
Labeling labeling artefact for Neprilozone in China. Version 2.4. Language: pl.
Artifact ID
LBL-064
Type
Labeling
Product
Market
China
Version
2.4
Language
pl
Status
Submitted
Last Reviewed
2024-03-24
Included Statements (8)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-190 | Safety | SmPC Section 4.1 | Patients should be advised not to drive or operate machinery if they experience … | 2024-04-22 |
| STMT-191 | Interaction | SmPC Section 4.3 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-03-01 |
| STMT-192 | Dosing | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-02-09 |
| STMT-193 | Special Population | SmPC Section 5.2 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2024-05-26 |
| STMT-194 | Contraindication | SmPC Section 4.8 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-02-07 |
| STMT-195 | Efficacy | SmPC Section 4.1 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-01-04 |
| STMT-196 | Safety | SmPC Section 4.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-03-22 |
| STMT-197 | Contraindication | SmPC Section 5.1 | The recommended dose is 10 mg once daily administered orally.… | 2023-06-29 |
Change History
New indication added
Interaction section update
Updated section 4.4 — special warnings
Posology revision
Posology revision
Harmonisation to core label