IFU — Thymomax
IFU labeling artefact for Thymosilib in Singapore. Version 14.5. Language: es.
Artifact ID
LBL-017
Type
IFU
Product
Market
Singapore
Version
14.5
Language
es
Status
Approved
Last Reviewed
2023-06-10
Included Statements (6)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-049 | Contraindication | SmPC Section 4.4 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-12-06 |
| STMT-050 | Efficacy | SmPC Section 4.5 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2024-03-15 |
| STMT-051 | Interaction | Core Data Sheet | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-04-19 |
| STMT-052 | Contraindication | SmPC Section 4.1 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-09-23 |
| STMT-053 | Safety | SmPC Section 4.8 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2022-11-07 |
| STMT-054 | Safety | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-05-04 |
Change History
New indication added