SmPC — Respimax
SmPC labeling artefact for Respiralimab in Italy. Version 14.6. Language: ko.
Artifact ID
LBL-012
Type
SmPC
Product
Market
Italy
Version
14.6
Language
ko
Status
Active
Last Reviewed
2023-09-26
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-034 | Special Population | SmPC Section 4.4 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2024-05-17 |
| STMT-035 | Dosing | SmPC Section 4.4 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-04-18 |
| STMT-036 | Safety | SmPC Section 4.2 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-03-19 |
| STMT-037 | PK | SmPC Section 4.1 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2024-01-12 |
| STMT-038 | Contraindication | SmPC Section 4.2 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-12-30 |
| STMT-039 | Dosing | SmPC Section 4.4 | Patients should be advised not to drive or operate machinery if they experience … | 2024-05-18 |
| STMT-040 | Special Population | SmPC Section 4.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2022-11-09 |
| STMT-041 | Efficacy | SmPC Section 5.1 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2022-12-07 |
| STMT-042 | Efficacy | SmPC Section 4.8 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-09-28 |
| STMT-043 | Interaction | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-04-23 |
Change History
Interaction section update
Harmonisation to core label
Updated section 4.4 — special warnings
Harmonisation to core label
Harmonisation to core label