IFU — Tisavance
IFU labeling artefact for Tisagenlecleux-B in Poland. Version 19.8. Language: pl.
Artifact ID
LBL-025
Type
IFU
Product
Market
Poland
Version
19.8
Language
pl
Status
In Progress
Last Reviewed
2024-07-12
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| 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 |
| STMT-077 | Dosing | SmPC Section 4.2 | This product has been designated as an orphan medicine in the European Union.… | 2023-10-29 |
| STMT-078 | Special Population | SmPC Section 4.1 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2024-02-02 |
| STMT-079 | PK | SmPC Section 4.2 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-10-16 |
| STMT-080 | Dosing | SmPC Section 4.1 | The recommended dose is 10 mg once daily administered orally.… | 2023-09-21 |
| STMT-081 | Efficacy | SmPC Section 4.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2023-07-08 |
| STMT-082 | Safety | SmPC Section 4.5 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-09-02 |
Change History
New indication added
Section 4.8 ADR update
Interaction section update
Updated section 4.4 — special warnings