SmPC — Alzaclear
SmPC labeling artefact for Alzabistat in United Kingdom. Version 7.4. Language: sv.
Artifact ID
LBL-038
Type
SmPC
Product
Market
United Kingdom
Version
7.4
Language
sv
Status
Submitted
Last Reviewed
2023-11-14
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-112 | Contraindication | SmPC Section 5.2 | Patients should be advised not to drive or operate machinery if they experience … | 2023-06-07 |
| STMT-113 | Contraindication | SmPC Section 4.5 | The recommended dose is 10 mg once daily administered orally.… | 2023-07-29 |
| STMT-114 | Interaction | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-08-25 |
| STMT-115 | Contraindication | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2024-01-20 |
| STMT-116 | Safety | SmPC Section 4.5 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-07-26 |
| STMT-117 | Dosing | SmPC Section 5.1 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-12-17 |
| STMT-118 | Efficacy | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2022-11-22 |
| STMT-119 | Contraindication | SmPC Section 5.1 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2024-05-18 |
| STMT-120 | PK | SmPC Section 4.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-06-19 |
| STMT-121 | Safety | SmPC Section 4.1 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2024-02-19 |
Change History
Harmonisation to core label