IFU — Neuraclair
IFU labeling artefact for Neuravastatin in Australia. Version 7.8. Language: sv.
Artifact ID
LBL-037
Type
IFU
Product
Market
Australia
Version
7.8
Language
sv
Status
Pending
Last Reviewed
2024-04-21
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-109 | PK | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-01-03 |
| STMT-110 | Contraindication | SmPC Section 4.4 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-02-14 |
| STMT-111 | Interaction | SmPC Section 4.1 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-01-02 |
| 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 |
Change History
Interaction section update
Harmonisation to core label