| Code | 9581D | ||||||||||
| MA number | 16/0153/18-S | ||||||||||
| Product Form: | plv iol 20x3000 IU+20x5,6 ml solv. (liek.inj.skl.+liek.inj.skl.+aplikač.súprava) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 14.05.2018 |
| Pediatric posology: | Yes |
| SPC: |
SPC Berinert_2000 IU_3000_IU_02.2022.pdf
|
| PIL: |
PIL Berinert 3000 IU_02.2022.pdf
|
| Safety feature | Yes |
| Data update: | 02.02.2022 |
