Code | 86049 | ||||||||||
MA number | EU/1/08/497/007 | ||||||||||
Product Form: | plv iol 1x(500 µg + 1,2 ml solv.) (liek.inj.skl.+napl.inj.striek.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: | 36 | ||||||||||
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: | 11.01.2010 |
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 |