| Code | 26078 | ||||||||||
| MA number | 75/0065/18-S | ||||||||||
| Product Form: | plv iio 1x1000 IU+1x20 ml solv. (liek.inj.skl.+liek.inj.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | CSL Behring GmbH, Germany | ||||||||||
| Therapeutic Class: | 75 - SUBSTITUTIO SANGUINIS (A KRVNÉ DERIVÁTY) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| 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: | 06.06.1984 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Kybernin P 500 IU_1000 IU_04.2023.pdf
|
| PIL: |
PIL_Kybernin P 500 IU_1000 IU_04.2023.pdf
|
| Safety feature | Yes |
| Data update: | 23.02.2018 |
