Labeling — Retinacor
Labeling labeling artefact for Retinavab in Taiwan. Version 14.8. Language: zh.
Artifact ID
LBL-046
Type
Labeling
Product
Market
Taiwan
Version
14.8
Language
zh
Status
Approved
Last Reviewed
2024-04-03
Included Statements (4)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-136 | Contraindication | SmPC Section 4.3 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-05-14 |
| STMT-137 | Contraindication | SmPC Section 4.2 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2023-09-18 |
| STMT-138 | PK | SmPC Section 4.5 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2023-10-17 |
| STMT-139 | Dosing | SmPC Section 4.1 | Patients should be advised not to drive or operate machinery if they experience … | 2023-05-10 |
Change History
Interaction section update
Harmonisation to core label
Section 4.8 ADR update
New indication added