IFU — Haemovance
IFU labeling artefact for Haemoferrin in South Korea. Version 3.6. Language: pl.
Artifact ID
LBL-015
Type
IFU
Product
Market
South Korea
Version
3.6
Language
pl
Status
In Progress
Last Reviewed
2023-06-26
Included Statements (10)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-043 | Interaction | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-04-23 |
| STMT-044 | Contraindication | SmPC Section 5.1 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-01-20 |
| STMT-045 | Interaction | SmPC Section 4.3 | The recommended dose is 10 mg once daily administered orally.… | 2024-06-16 |
| 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 |
Change History
Harmonisation to core label
Interaction section update
Updated section 4.4 — special warnings
Updated section 4.4 — special warnings
Interaction section update