Code | 7822C | ||||||||||
MA number | 16/0152/18-S | ||||||||||
Product Form: | plv iol 1x2000 IU+1x4 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 |
PIL: | PIL Berinert 2000 IU_12.2021.pdf |
SPC: | SPC Berinert_2000 IU_3000_IU_02.2022.pdf |
Safety feature | Yes |
Data update: | 11.11.2020 |