Labeling — Retinacor
Labeling labeling artefact for Retinavab in Taiwan. Version 9.6. Language: zh.
Artifact ID
LBL-016
Type
Labeling
Product
Market
Taiwan
Version
9.6
Language
zh
Status
In Progress
Last Reviewed
2023-12-23
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-046 | PK | SmPC Section 4.4 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2023-09-30 |
| STMT-047 | Efficacy | SmPC Section 4.5 | Fertility studies in animals have not shown any adverse effects on fertility.… | 2022-12-29 |
| STMT-048 | Dosing | SmPC Section 4.2 | Patients should be advised not to drive or operate machinery if they experience … | 2023-03-09 |
| 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 |
| STMT-055 | Dosing | SmPC Section 4.1 | This product has been designated as an orphan medicine in the European Union.… | 2023-11-27 |
Change History
New indication added
New indication added
Interaction section update
Harmonisation to core label
New indication added
Section 4.8 ADR update