The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Labetalol 5 mg/ml solution for injection/ infusion

5 milligram(s)/millilitre Solution for injection/infusion

S.A.L.F. S.p.A. Laboratorio FarmacologicoPA22760/001/001

Main Information

Trade NameLabetalol 5 mg/ml solution for injection/ infusion
Active SubstancesLABETALOL HYDROCHLORIDE
Strength5 milligram(s)/millilitre
Dosage FormSolution for injection/infusion
Licence HolderS.A.L.F. S.p.A. Laboratorio Farmacologico
Licence NumberPA22760/001/001

Group Information

ATC CodeC07AG01 labetalol

Status

Authorised/WithdrawnAuthorised
Licence Issued19/08/2019
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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