IFU — Infeclear
IFU labeling artefact for Infectivir in France. Version 10.5. Language: sv.
Artifact ID
LBL-011
Type
IFU
Product
Market
France
Version
10.5
Language
sv
Status
In Progress
Last Reviewed
2023-09-28
Included Statements (6)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-031 | Safety | SmPC Section 4.3 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-03-16 |
| STMT-032 | PK | SmPC Section 4.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-01-21 |
| STMT-033 | Special Population | SmPC Section 4.4 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-06-14 |
| STMT-034 | Special Population | SmPC Section 4.4 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2024-05-17 |
| STMT-035 | Dosing | SmPC Section 4.4 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-04-18 |
| STMT-036 | Safety | SmPC Section 4.2 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-03-19 |
Change History
Posology revision
Harmonisation to core label