Code | 3200A | ||||||||||
MA number | EU/1/08/442/018 | ||||||||||
Product Form: | cps dur 60x1x110 mg (blis.Al/Al biely) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Boehringer Ingelheim International GmbH, Germany | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 18.03.2008 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHPC Pradaxa 19 12 2012.pdf |
Dokument: | dabigatran etexilát_Príručka pre predpisujúceho lekára VTE.pdf |
Dokument: | dabigatran etexilát_Príručka pre predpisujúceho lekára CMP.pdf |
Dokument: | dabigatran etexilát_Príručka pre predpisujúceho lekára - pediatria.pdf |
Safety feature | Yes |
Data update: | 22.02.2021 |