| Code | 5688B | ||||||||||
| MA number | 16/0366/15-S | ||||||||||
| Product Form: | plv iol 1x500 IU+1x5 ml solv.(liek.inj.skl.+liek.inj.skl.+prenos.zariadenie) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 02.09.2015 |
| Pediatric posology: | Yes |
| SPC: |
SPC_Optivate_03.2021.pdf
|
| PIL: |
PIL_Optivate_11.2023.pdf
|
| Safety feature | Yes |
| Data update: | 12.04.2019 |
