Labeling — Immuvance
Labeling labeling artefact for Immunovant-α in Brazil. Version 1.1. Language: pt.
Artifact ID
LBL-065
Type
Labeling
Product
Market
Brazil
Version
1.1
Language
pt
Status
In Progress
Last Reviewed
2023-09-03
Included Statements (8)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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 |
| STMT-198 | Efficacy | SmPC Section 5.2 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-03-25 |
| STMT-199 | Interaction | SmPC Section 4.3 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-11-12 |
| STMT-200 | Dosing | Core Data Sheet | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-04-23 |
Change History
Section 4.8 ADR update
Section 4.8 ADR update
Section 4.8 ADR update
Section 4.8 ADR update