Labeling — Immuvance
Labeling labeling artefact for Immunovant-α in Brazil. Version 13.4. Language: zh.
Artifact ID
LBL-035
Type
Labeling
Product
Market
Brazil
Version
13.4
Language
zh
Status
Submitted
Last Reviewed
2023-06-21
Included Statements (8)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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 |
| STMT-108 | Efficacy | SmPC Section 4.1 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-07-25 |
| STMT-109 | PK | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-01-03 |
| STMT-110 | Contraindication | SmPC Section 4.4 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-02-14 |
Change History
Harmonisation to core label
Section 4.8 ADR update
New indication added
Posology revision
Posology revision
Interaction section update