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Levosimendan 2.5 mg/ml concentrate for solution for infusion



AS KalceksPA2165/015/001

Main Information

Trade NameLevosimendan 2.5 mg/ml concentrate for solution for infusion
Active SubstancesLevosimendan
Dosage FormConcentrate for solution for infusion
Licence HolderAS Kalceks
Licence NumberPA2165/015/001

Group Information

ATC CodeC01CX08 levosimendan

Status

License statusAuthorised
Licence Issued01/04/2022
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceLevosimendan is for in-hospital use only. It should be administered in a hospital setting where adequate monitoring facilities and expertise with the use of inotropic agents are available.
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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