Labeling — Atezovance
Labeling labeling artefact for Atezolimumab-R in Portugal. Version 9.5. Language: es.
Artifact ID
LBL-029
Type
Labeling
Product
Market
Portugal
Version
9.5
Language
es
Status
Pending
Last Reviewed
2023-12-15
Included Statements (8)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-085 | Interaction | Core Data Sheet | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2024-02-20 |
| STMT-086 | Safety | SmPC Section 4.2 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-06-28 |
| STMT-087 | Efficacy | SmPC Section 4.4 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-06-22 |
| STMT-088 | Special Population | SmPC Section 4.2 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-04-20 |
| STMT-089 | PK | SmPC Section 5.1 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-10-23 |
| STMT-090 | Special Population | SmPC Section 4.3 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2023-04-02 |
| STMT-091 | PK | Core Data Sheet | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-04-14 |
| STMT-092 | PK | SmPC Section 4.4 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… | 2023-02-17 |
Change History
Posology revision
Interaction section update
Updated section 4.4 — special warnings
Interaction section update
Harmonisation to core label
Updated section 4.4 — special warnings