| Code | 65619 | ||||||||||
| MA number | 16/0111/09-S | ||||||||||
| Product Form: | plv iio 1x500 IU+1x10 ml solv. (liek.inj.skl.+liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| 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 - known active substance |
| MA issued: | 24.02.2009 |
| Pediatric posology: | Yes |
| SPC: |
SPC Berinert_500 IU_1500 IU_12.2021.pdf
|
| PIL: |
PIL Berinert 500 IU_12.2021.pdf
|
| Safety feature | Yes |
| Data update: | 18.03.2019 |
