| Code | 1120D | ||||||||||
| MA number | 39/0100/19-S | ||||||||||
| Product Form: | sol inf 8x1500 ml (vak polyolefínový) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Medical Care Deutschland GmbH, Germany | ||||||||||
| Therapeutic Class: | 39 - SOLI A IONTY PRO P.O. A PARENT. APLIKÁCIU | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | bag polyolefin | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 07.06.2019 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Calrecia_sol_inf_09_2023.pdf
|
| SPC: |
SPC_Calrecia_sol inf_09_2023.pdf
|
| Safety feature | Yes |
| Data update: | 31.05.2023 |
