| Code | 44346 | ||||||||
| MA number | 12/0250/07-S | ||||||||
| Product Form: | dis ijf 5x10 ml/500 mg (liek.inj.skl.) | ||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
| Type of procedure: | Decentralised | ||||||||
| MAH, country: | Vifor France, France | ||||||||
| Therapeutic Class: | 12 - ANTIANAEMICA | ||||||||
| ATC: |
|
||||||||
| Shelf life: | 48 | ||||||||
| Container: | glass vial | ||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 15.08.2007 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Dokument: |
DHPC železo iv 28 10 2013.pdf
|
| Dokument: |
DHPC železo Annex II_SK.pdf
|
| Dokument: |
DHPC železo Annex I_SK.pdf
|
| SPC: |
SPC_Ferinject_05.2025.pdf
|
| PIL: |
PIL_Ferinject_05.2025.pdf
|
| Dokument: |
SK_Ferric carboxymaltose core educational materials for HCPs_v1_Apr 2024_11nov25.pdf
|
| Dokument: |
SK_Ferric carboxymaltose core educational materials for patients_v1_Apr 2024_10nov25.pdf
|
| Safety feature | Yes |
| Data update: | 31.01.2025 |
