Code | 3804A | ||||||||||
MA number | EU/1/11/691/009 | ||||||||||
Product Form: | tbl flm 60x5 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Bristol-Myers Squibb/Pfizer EEIG , Ireland | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 18.05.2011 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 08.02.2021 |