| Code | 1113E | ||||||||
| MA number | 87/0153/22-S | ||||||||
| Product Form: | sol inf 8x1500 ml/204 mmol (vak PP/elastomér+sys.pripoj.SecuNect) | ||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||
| Type of procedure: | Decentralised | ||||||||
| MAH, country: | Fresenius Medical Care Deutschland GmbH, Germany | ||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||
| ATC: |
|
||||||||
| Shelf life: | 24 | ||||||||
| Route of admin.: | Extracorporeal use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 27.06.2022 |
| Validity: | 27.06.2027 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
|
| SPC: |
|
| Safety feature | Yes |
| Data update: | 01.07.2022 |