PIL — Atezovance
PIL labeling artefact for Atezolimumab-R in Portugal. Version 1.3. Language: de.
Artifact ID
LBL-059
Type
PIL
Product
Market
Portugal
Version
1.3
Language
de
Status
Approved
Last Reviewed
2023-12-08
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-175 | Safety | SmPC Section 4.5 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-03-25 |
| STMT-176 | Dosing | SmPC Section 4.2 | Patients should be advised not to drive or operate machinery if they experience … | 2022-12-17 |
| STMT-177 | Dosing | SmPC Section 5.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-06-17 |
| STMT-178 | Interaction | SmPC Section 4.8 | The medicinal product should not be used during pregnancy unless clearly necessa… | 2023-01-16 |
| STMT-179 | Efficacy | SmPC Section 4.2 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2022-12-28 |
| STMT-180 | Special Population | Core Data Sheet | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2024-04-17 |
| STMT-181 | PK | SmPC Section 4.3 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-02-25 |
| STMT-182 | Safety | SmPC Section 4.1 | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-09-28 |
| STMT-183 | Contraindication | SmPC Section 4.8 | Patients should be advised not to drive or operate machinery if they experience … | 2023-06-13 |
| STMT-184 | Dosing | Core Data Sheet | No dose adjustment is required in patients with mild to moderate hepatic impairm… | 2023-05-20 |
Change History
Interaction section update
Harmonisation to core label
Updated section 4.4 — special warnings