SmPC — Tisavance
SmPC labeling artefact for Tisagenlecleux-B in Poland. Version 2.9. Language: es.
Artifact ID
LBL-055
Type
SmPC
Product
Market
Poland
Version
2.9
Language
es
Status
Pending
Last Reviewed
2023-05-16
Included Statements (6)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-163 | Special Population | SmPC Section 4.2 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2022-11-03 |
| STMT-164 | Safety | SmPC Section 4.3 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-12-10 |
| STMT-165 | Dosing | SmPC Section 5.2 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2022-11-18 |
| STMT-166 | Efficacy | SmPC Section 4.3 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-02-05 |
| STMT-167 | Special Population | SmPC Section 4.4 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-01-27 |
| STMT-168 | Dosing | SmPC Section 5.1 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2024-01-13 |
Change History
Updated section 4.4 — special warnings
Harmonisation to core label
New indication added