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PRODUCT DETAIL

Ledraxen 10 000 IU (100 mg)/1 ml injekčný roztok v naplnenej injekčnej striekačke

Code 2829E
MA number 16/0024/23-S
Product Form: sol iru 6x10 000 IU (100 mg)/1 ml (striek.inj.napl.skl. s bezp. systémom)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AB Heparin group
B01AB05 Enoxaparin
Shelf life: 36
Route of admin.: Extracorporeal, intravenous and subcutaneous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(4) similar biological application
MA issued: 15.02.2023
Validity: 15.02.2028
MA renewed: Renewal application submitted
PIL: PIL_Ledraxen_injekčný roztok v naplnenej injekčnej striekačke_01_2023.pdf  
SPC: SPC_Ledraxen_injekčný roztok v naplnenej injekčnej striekačke_01_2023.pdf  
Safety feature Yes
Data update: 21.02.2023
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