| Code | 6343C | ||||||||||
| MA number | EU/1/08/497/009 | ||||||||||
| Product Form: | plv ino 1x125 µg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | glass container | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 09.11.2017 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Nplate Dávkovacia kalkulačka.pdf
|
| Dokument: |
Nplate Výber a školenie dospelých pacientov.pdf
|
| Dokument: |
Nplate_Balíček pre podávanie v domácom prostredí.pdf
|
| Dokument: |
Nplate_Dennik pacienta.pdf
|
| Dokument: |
Nplate_Kontrolný zoznam pre svojpomocné podávanie.pdf
|
| Dokument: |
Nplate_Návod na podávanie lieku.pdf
|
| Dokument: |
Nplate_Podložka na prípravu.pdf
|
| Dokument: |
Nplate_Priručka Krok za krokom.pdf
|
| Safety feature | Yes |
| Data update: | 19.06.2018 |
