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PRODUCT DETAIL

Actilyse 20 mg

Code 60382
MA number 16/0104/13-S
Product Form: plv iio 2x20 mg+2x20 ml solv. (liek.inj.skl.+liek.inj.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AD Enzymes
B01AD02 Alteplase
Shelf life: 36
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 01.07.1992
Pediatric contraindication: Yes
Pediatric warnings: Yes
SPC: SPC_Actilyse 20 mg_50 mg_02.2024.pdf  
PIL: PIL_Actilyse 20 mg_50 mg_02.2024.pdf  
Safety feature Yes
Data update: 11.04.2018
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