| Code | 8890E | ||||||||
| MA number | 12/0036/25-S | ||||||||
| Product Form: | dis ijf 1x20 ml/1 000 mg (liek.inj.skl.) | ||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||
| Type of procedure: | Decentralised | ||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||
| Therapeutic Class: | 12 - ANTIANAEMICA | ||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||
| Container: | colourless glass vial (type 1), rubber stopper (type 1) | ||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 10.02.2025 |
| Validity: | 10.02.2030 |
| Pediatric posology: | Yes |
| SPC: |
SPC_Ferric carboxymaltose Teva 50 mg železa_ml injekčná_infúzna disperzia_02_2025.pdf
|
| PIL: |
PIL_Ferric carboxymaltose Teva 50 mg železa_ml injekčná_infúzna disperzia_02.2025.pdf
|
| Safety feature | Yes |
| Data update: | 12.02.2025 |
