Labeling — Upadvex
Labeling labeling artefact for Upadacitimab in South Africa. Version 20.2. Language: en.
Artifact ID
LBL-053
Type
Labeling
Product
Market
South Africa
Version
20.2
Language
en
Status
Active
Last Reviewed
2024-05-17
Included Statements (7)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-157 | PK | Core Data Sheet | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-07-07 |
| STMT-158 | PK | Core Data Sheet | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-11-13 |
| STMT-159 | Special Population | SmPC Section 4.8 | The recommended dose is 10 mg once daily administered orally.… | 2024-02-15 |
| STMT-160 | PK | SmPC Section 5.2 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2024-01-02 |
| STMT-161 | PK | SmPC Section 4.2 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-07-17 |
| STMT-162 | Contraindication | SmPC Section 4.3 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-09-21 |
| STMT-163 | Special Population | SmPC Section 4.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2022-11-03 |
Change History
New indication added
Harmonisation to core label