Labeling — Immuvance
Labeling labeling artefact for Immunovant-α in Brazil. Version 1.2. Language: pt.
Artifact ID
LBL-005
Type
Labeling
Product
Market
Brazil
Version
1.2
Language
pt
Status
In Progress
Last Reviewed
2023-06-21
Included Statements (3)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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 |
Change History
New indication added
Posology revision
Updated section 4.4 — special warnings