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SAI - Detailed view
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DEFITELIO Inf Konz 200 mg/2.5ml Durchstf 10 Stk
Drug
Defitelio, Konzentrat zur Herstellung einer Infusionslösung
Behandlung von schwerer hepatischer venooklusiver Erkrankung bei hämatopoetischer Stammzelltransplantation
06.03.0. – anticoagulants
HAM – Human medicine
LSPA – Parenteral solution
BT – biological medicines
A – Dispensed once only on prescription by a physician or veterinarian (A)
Z – approved
9/21/2020
9/20/2025
Dosage strength
Defitelio 80 mg/ml, Konzentrat zur Herstellung einer Infusionslösung
Behandlung von schwerer hepatischer venooklusiver Erkrankung bei hämatopoetischer Stammzelltransplantation
01
Z – approved
Package
7680676670016
No information made available
A/R – Authorised / referenced
10 vial(s)
001
Z – approved
Declaration
Component
80 mg defibrotidum
natrii citras dihydricus
natrii hydroxidum
acidum hydrochloridum
aqua ad iniectabile
max. 8.16 mg natrium
natrii hydroxidum
acidum hydrochloridum
aqua ad iniectabile
max. 8.16 mg natrium
Authorisation holder
7601001383715
Jazz Pharmaceuticals
Grafenauweg 8
6300 Zug (ZG)
Grafenauweg 8
6300 Zug (ZG)
Date of revision of the text
11/1/2023
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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.