PIL — Infeclear
PIL labeling artefact for Infectivir in France. Version 16.2. Language: de.
Artifact ID
LBL-041
Type
PIL
Product
Market
France
Version
16.2
Language
de
Status
Submitted
Last Reviewed
2023-09-07
Included Statements (6)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-121 | Safety | SmPC Section 4.1 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2024-02-19 |
| STMT-122 | Interaction | SmPC Section 4.5 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2024-06-14 |
| STMT-123 | PK | SmPC Section 4.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2022-11-03 |
| STMT-124 | Dosing | SmPC Section 4.4 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2024-03-10 |
| STMT-125 | Contraindication | SmPC Section 4.8 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-09-27 |
| STMT-126 | Dosing | Core Data Sheet | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-04-30 |
Change History
Interaction section update
New indication added