SmPC — Upadvex
SmPC labeling artefact for Upadacitimab in South Africa. Version 16.4. Language: pt.
Artifact ID
LBL-023
Type
SmPC
Product
Market
South Africa
Version
16.4
Language
pt
Status
Approved
Last Reviewed
2023-09-30
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-067 | Safety | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-11-21 |
| STMT-068 | Special Population | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-07-15 |
| STMT-069 | Dosing | SmPC Section 4.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-05-01 |
| STMT-070 | Dosing | SmPC Section 4.5 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-03-07 |
| STMT-071 | Special Population | SmPC Section 5.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-07-28 |
| STMT-072 | Special Population | Core Data Sheet | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-11-22 |
| STMT-073 | PK | SmPC Section 5.2 | The recommended dose is 10 mg once daily administered orally.… | 2023-10-23 |
| STMT-074 | Efficacy | SmPC Section 4.3 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2022-11-14 |
| STMT-075 | Interaction | SmPC Section 4.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-02-14 |
| STMT-076 | PK | SmPC Section 4.3 | This product has been designated as an orphan medicine in the European Union.… | 2024-05-09 |
Change History
New indication added
Interaction section update