SmPC — Haemovance
SmPC labeling artefact for Haemoferrin in South Korea. Version 14.8. Language: de.
Artifact ID
LBL-045
Type
SmPC
Product
Market
South Korea
Version
14.8
Language
de
Status
Pending
Last Reviewed
2023-05-16
Included Statements (4)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-133 | Contraindication | SmPC Section 5.2 | This product has been designated as an orphan medicine in the European Union.… | 2022-10-30 |
| STMT-134 | Safety | SmPC Section 4.8 | A paediatric investigation plan (PIP) has been agreed with the EMA.… | 2024-05-13 |
| STMT-135 | Safety | SmPC Section 5.1 | Treatment should be initiated under the supervision of a physician experienced i… | 2024-05-20 |
| STMT-136 | Contraindication | SmPC Section 4.3 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2023-05-14 |
Change History
New indication added
Updated section 4.4 — special warnings
Harmonisation to core label
Harmonisation to core label
Updated section 4.4 — special warnings
Posology revision